Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alamar Biosciences, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
266 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943756 | MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYC | Alamar Biosciences, Inc. | 1995-02-17 | 199 | 0 |
| K944723 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION | Alamar Biosciences, Inc. | 1994-10-21 | 25 | 0 |
| K933885 | ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBI | Alamar Biosciences, Inc. | 1993-11-16 | 98 | 0 |
| K930478 | READAR | Alamar Biosciences, Inc. | 1993-10-22 | 266 | 0 |
| K925859 | READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS | Alamar Biosciences, Inc. | 1993-07-08 | 233 | 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