Bio-Rad: FDA clearances and approvals
Bio-Rad has 319 FDA 510(k) clearances (first 1976, latest 2017), plus 1 PMA decision, across 85 product codes in 7 review panels. Median 510(k) review time: 39 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 105 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 262 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bio-Rad's cleared 510(k)s took a median 262 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 61 | 61 |
| DIF | Drug Mixture Control Materials | 31 | 31 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 21 | 21 |
| LCP | Assay, Glycosylated Hemoglobin | 15 | 15 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 14 | 14 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 9 | 9 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 9 | 9 |
| LKJ | Antinuclear Antibody, Antigen, Control | 9 | 9 |
| GGN | Plasma, Coagulation Control | 7 | 7 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 6 | 6 |
Plus 75 more product codes.
Review panels
- Clinical Chemistry (166)
- Clinical Toxicology (54)
- Hematology (38)
- Immunology (35)
- Microbiology (16)
- Ophthalmic (10)
- Orthopedic (1)
Most recent Bio-Rad 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171061 | MRSASelect II | JSO | 2017-12-28 | 262 |
| K122187 | VRESELECT CULTURE MEDIUM | JSO | 2012-11-06 | 105 |
| K103684 | VRESELECT CULTURE MEDIUM | JSO | 2011-10-21 | 308 |
| K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | NOM | 2011-01-13 | 412 |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | JSO | 2010-10-29 | 241 |
| K081362 | PLATELIA LYME IGM | LSR | 2008-06-26 | 42 |
| K081212 | MRSASELECT - EXTENDED INCUBATION | JSO | 2008-06-13 | 45 |
| K080012 | PLATELIA LYME IGG ASSAY | LSR | 2008-05-08 | 126 |
| K070361 | MRSASELECT | JSO | 2007-09-13 | 218 |
| K060641 | PLATELIA ASPERGILLUS EIA, MODEL 62793 | NOM | 2006-06-02 | 84 |
309 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P880032 | PMA | BIO-RAD CYCLOSPORINE BY HPLC TEST | 1989-07-24 |
Recalls
openFDA lists no recalls under a recalling firm named Bio-Rad.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bio-Rad have?
Bio-Rad has 319 FDA 510(k) clearances (first 1976, latest 2017), plus 1 PMA decision, across 85 product codes in 7 review panels.
How long does FDA take to clear Bio-Rad's 510(k)s?
The median time from FDA receipt to decision across Bio-Rad's cleared 510(k)s is 39 days.
What devices does Bio-Rad make?
Its most frequent FDA product codes are JJY (Multi-Analyte Controls, All Kinds (Assayed), 61); DIF (Drug Mixture Control Materials, 31); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 21).
Has Bio-Rad had device recalls?
openFDA lists no recalls under a recalling firm name matching Bio-Rad. Related entities may recall under other names.
Next steps
- See all 319 Bio-Rad clearances with predicates and recalls
- Run predicate analysis for product code JJY, Bio-Rad's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.