Bio-Rad, Diagnostics Grp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Bio-Rad, Diagnostics Grp.” (first 2007, latest 2012), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 58 days. 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 | 1 | 22 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| GGN | Plasma, Coagulation Control | 1 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Hematology (1)
- Clinical Toxicology (1)
Most recent Bio-Rad, Diagnostics Grp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121794 | LIQUICHEK URINE CHEMISTRY CONTROL | JJY | 2012-07-11 | 22 |
| K100727 | LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK | JJY | 2010-09-14 | 183 |
| K072835 | LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK | JJY | 2007-12-11 | 69 |
| K072721 | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC | DIF | 2007-12-11 | 76 |
| K071319 | I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 | GGN | 2007-06-26 | 47 |
| K070848 | LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X | JJW | 2007-04-25 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Bio-Rad, Diagnostics Grp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio-Rad, Diagnostics Grp.?
FDA lists 6 510(k) clearances under the applicant name “Bio-Rad, Diagnostics Grp.” (first 2007, latest 2012), across 4 product codes in 3 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, Diagnostics Grp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Rad, Diagnostics Grp. is 58 days.
Which FDA product codes appear under Bio-Rad, Diagnostics Grp.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 3); DIF (Drug Mixture Control Materials, 1); GGN (Plasma, Coagulation Control, 1).
Next steps
- See all 6 Bio-Rad, Diagnostics Grp. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Bio-Rad, Diagnostics Grp.'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.