Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio-Rad Laboratories Inc., Clinical Systems Divisi — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080911 | VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEW | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2008-05-02 | 30 | 0 |
| K070819 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2007-06-25 | 91 | 5 |
| K063643 | MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THA | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2006-12-27 | 20 | 1 |
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