Bio-Rad Laboratories: FDA 510(k) clearances across all its applicant names
FDA lists 458 510(k) clearances, 5 PMA and 1 De Novo decisions across the 5 applicant names Caduvo groups under Bio-Rad Laboratories, first 1976, latest 2019. Median 510(k) review time across these names: 44 days. Since 2017 the median was 95 days, against 174 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 14 | 36 |
| 2013 | 10 | 34 |
| 2014 | 6 | 44 |
| 2015 | 5 | 205 |
| 2016 | 2 | 177 |
| 2017 | 5 | 90 |
| 2018 | 1 | 109 |
| 2019 | 2 | 162 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
The 5 FDA applicant names in this group
| Applicant name | 510(k) clearances | PMA | De Novo | Years |
|---|---|---|---|---|
| Bio-Rad | 319 | 1 | 0 | 1976–2017 |
| Bio-Rad Laboratories, Inc. | 127 | 4 | 1 | 1991–2019 |
| Bio-Rad, Diagnostics Grp. | 6 | 0 | 0 | 2007–2012 |
| Bio-Rad Laboratories, Inc., Clinical Systems Divis | 3 | 0 | 0 | 2012–2013 |
| Bio-Rad Laboratories Inc., Clinical Systems Divisi | 3 | 0 | 0 | 2006–2008 |
Review time against the same product codes
Since 2017, 510(k)s cleared under these names took a median 95 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 90 | 90 |
| DIF | Drug Mixture Control Materials | 37 | 37 |
| LCP | Assay, Glycosylated Hemoglobin | 28 | 28 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 24 | 24 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 14 | 14 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 11 | 11 |
| LKJ | Antinuclear Antibody, Antigen, Control | 11 | 11 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 9 | 9 |
| GGN | Plasma, Coagulation Control | 8 | 8 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 7 | 7 |
Plus 110 more product codes.
Review panels
- Clinical Chemistry (233)
- Clinical Toxicology (61)
- Hematology (58)
- Immunology (52)
- Microbiology (48)
- Ophthalmic (10)
- Orthopedic (1)
- Pathology (1)
Most recent Bio-Rad Laboratories 510(k) clearances
| 510(k) | Device | Applicant name | Product code | Decision date | Review days |
|---|---|---|---|---|---|
| K183446 | BioPlex 2200 Lyme Total | Bio-Rad Laboratories, Inc. | LSR | 2019-03-12 | 90 |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. | OYX | 2019-02-13 | 233 |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | Bio-Rad Laboratories, Inc. | MRG | 2018-06-22 | 109 |
| K171061 | MRSASelect II | Bio-Rad | JSO | 2017-12-28 | 262 |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | Bio-Rad Laboratories, Inc. | GKA | 2017-09-13 | 100 |
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | Bio-Rad Laboratories, Inc. | PUQ | 2017-05-19 | 87 |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | Bio-Rad Laboratories, Inc. | LIP | 2017-05-11 | 90 |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | Bio-Rad Laboratories, Inc. | JJY | 2017-01-10 | 74 |
| K161687 | D-10 Hemoglobin A1c Program | Bio-Rad Laboratories, Inc. | PDJ | 2016-10-14 | 119 |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak | Bio-Rad Laboratories, Inc. | PMN | 2016-05-10 | 235 |
448 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150058 | De Novo | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 2016-03-28 |
| P060034 | PMA | BIO RAD MONOLISA ANTI-HBC IGM EIA | 2007-05-31 |
| P060031 | PMA | BIO-RAD MONOLISA ANTI-HBC EIA | 2007-04-27 |
| P050048 | PMA | MONOLISA ANTI-HBS EIA | 2006-08-25 |
| P880032 | PMA | BIO-RAD CYCLOSPORINE BY HPLC TEST | 1989-07-24 |
Recalls
89 product recalls in 66 recall events under these names; 10 initiated in the last five years.
Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
How this group is built
Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.
All Bio-Rad entity names; DiaMed (Swiss blood-typing, acquired 2007) included only as DIAMED AG. Left out: DIAMED DIVISION ILL TOOL WORKS and DIAMEDIX (unrelated companies with similar names).
Sources
Frequently asked questions
How many FDA 510(k) clearances are listed across Bio-Rad Laboratories's applicant names?
FDA lists 458 510(k) clearances, 5 PMA and 1 De Novo decisions across the 5 applicant names Caduvo groups under Bio-Rad Laboratories, first 1976, latest 2019. FDA records each applicant name separately; Caduvo adds up the names listed on this page.
Which FDA applicant names does Bio-Rad Laboratories file under?
The names with the most 510(k) clearances in this group are Bio-Rad (319); Bio-Rad Laboratories, Inc. (127); Bio-Rad, Diagnostics Grp. (6); Bio-Rad Laboratories, Inc., Clinical Systems Divis (3); Bio-Rad Laboratories Inc., Clinical Systems Divisi (3). The full list of 5 names is on this page.
How long does FDA take to clear Bio-Rad Laboratories 510(k)s?
The median time from FDA receipt to decision across 510(k)s cleared under these names is 44 days. Since 2017 the median was 95 days, against 174 days for all cleared 510(k)s in the same product codes.
Does the Bio-Rad Laboratories count include acquired companies?
Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.
Next steps
- See all 458 Bio-Rad Laboratories clearances with predicates and recalls
- Run predicate analysis for product code JJY, Bio-Rad Laboratories's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.
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