Bio-Rad Laboratories, Inc.: FDA filings under this applicant name
FDA lists 127 510(k) clearances under 2 spellings of the applicant name “Bio-Rad Laboratories, Inc.” (first 1991, latest 2019), plus 4 PMA and 1 De Novo decisions, across 60 product codes in 6 review panels. Median 510(k) review time under this name: 84 days. Since 2017 the median was 90 days, against 167 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Bio-Rad Laboratories, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 11 | 35 |
| 2013 | 8 | 44 |
| 2014 | 6 | 44 |
| 2015 | 5 | 205 |
| 2016 | 2 | 177 |
| 2017 | 4 | 88 |
| 2018 | 1 | 109 |
| 2019 | 2 | 162 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bio-Rad Laboratories, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 167 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 26 | 26 |
| LCP | Assay, Glycosylated Hemoglobin | 8 | 8 |
| DIF | Drug Mixture Control Materials | 5 | 5 |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 4 | 4 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 | 3 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 3 | 3 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 3 | 3 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 3 | 3 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 3 | 3 |
| PDJ | Hemoglobin A1c Test System | 3 | 3 |
Plus 50 more product codes.
Review panels
- Clinical Chemistry (63)
- Microbiology (32)
- Immunology (17)
- Hematology (13)
- Clinical Toxicology (6)
- Pathology (1)
Most recent Bio-Rad Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183446 | BioPlex 2200 Lyme Total | LSR | 2019-03-12 | 90 |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | OYX | 2019-02-13 | 233 |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | MRG | 2018-06-22 | 109 |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | GKA | 2017-09-13 | 100 |
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | 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 | 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 | JJY | 2017-01-10 | 74 |
| K161687 | D-10 Hemoglobin A1c Program | PDJ | 2016-10-14 | 119 |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak | PMN | 2016-05-10 | 235 |
| K150300 | Liquichek Cardiac Markers Plus Control LT | JJY | 2015-12-11 | 308 |
117 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 |
| P800025 | PMA | QUANTITOPE 125I AFP KIT AND CONTROL SERUM | 1984-01-13 |
Recalls
91 product recalls in 68 recall events; 10 initiated in the last five years. Most recent: 2025-05-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Bio-Rad Laboratories, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02401555: Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay (Completed, started 2013-04)
- NCT01226173: Dengue Virus NS1 Antigen (Bio-Rad) Clinical Protocol (Completed, started 2010-03)
SEC filings
BIO-RAD LABORATORIES, INC. (BIO, BIO-B): EDGAR filings, CIK 12208. An SEC registrant with the same name, matched by name only.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Bio-Rad Laboratories, Inc. (85)
- Bio-Rad Laboratories (47)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio-Rad Laboratories, Inc.?
FDA lists 127 510(k) clearances under 2 spellings of the applicant name “Bio-Rad Laboratories, Inc.” (first 1991, latest 2019), plus 4 PMA and 1 De Novo decisions, across 60 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bio-Rad Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Rad Laboratories, Inc. is 84 days. Since 2017: 90 days, versus 167 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bio-Rad Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 26); LCP (Assay, Glycosylated Hemoglobin, 8); DIF (Drug Mixture Control Materials, 5).
Next steps
- See all 127 Bio-Rad Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Bio-Rad Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.