Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio-Rad, Diagnostics Grp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
183 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121794 | LIQUICHEK URINE CHEMISTRY CONTROL | Bio-Rad, Diagnostics Grp. | 2012-07-11 | 22 | 0 |
| K100727 | LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQU | Bio-Rad, Diagnostics Grp. | 2010-09-14 | 183 | 0 |
| K072835 | LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MIN | Bio-Rad, Diagnostics Grp. | 2007-12-11 | 69 | 0 |
| K072721 | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMM | Bio-Rad, Diagnostics Grp. | 2007-12-11 | 76 | 0 |
| K071319 | I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND | Bio-Rad, Diagnostics Grp. | 2007-06-26 | 47 | 0 |
| K070848 | LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEV | Bio-Rad, Diagnostics Grp. | 2007-04-25 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda