Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alamar Biosciences Laboratory, Inc. · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
280 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941425 | ALAMAR ANTIBIOTIC SUSCEPTIBILITY | Alamar Biosciences Laboratory, Inc. | 1994-12-15 | 267 | 0 |
| K926248 | READER | Alamar Biosciences Laboratory, Inc. | 1994-05-17 | 519 | 0 |
| K926002 | ALAMAR BACTERIAL IDENTIFICATION TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1993-09-23 | 300 | 0 |
| K925951 | READAR | Alamar Biosciences Laboratory, Inc. | 1993-08-31 | 280 | 0 |
| K930469 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1993-06-25 | 148 | 0 |
| K930055 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1993-04-05 | 89 | 0 |
| K924500 | ANTIMICROBIAL SUSCEPTIBILITY TEST | Alamar Biosciences Laboratory, Inc. | 1992-11-30 | 87 | 0 |
| K922780 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1992-08-20 | 72 | 0 |
| K922003 | ANTIMICROBIAL SUSCETIBILITY TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1992-08-19 | 112 | 0 |
| K922168 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1992-07-28 | 81 | 0 |
| K911558 | ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN | Alamar Biosciences Laboratory, Inc. | 1991-05-15 | 37 | 0 |
| K911305 | ANTIMICROBIAL GENTAMICIN | Alamar Biosciences Laboratory, Inc. | 1991-04-22 | 28 | 0 |
| K911304 | ANTIMICROBIAL TOBRAMYCIN | Alamar Biosciences Laboratory, Inc. | 1991-04-22 | 28 | 0 |
| K911556 | ANTIMICROBIAL SUSCEPT. TEST PANEL TICARC./CLAVUL. | Alamar Biosciences Laboratory, Inc. | 1991-04-22 | 14 | 0 |
| K911555 | ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL. | Alamar Biosciences Laboratory, Inc. | 1991-04-22 | 14 | 0 |
| K911557 | ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN | Alamar Biosciences Laboratory, Inc. | 1991-04-22 | 14 | 0 |
| K911559 | ANTIMICROBIAL SUSCEPT. TEST PANEL CEFONICID | Alamar Biosciences Laboratory, Inc. | 1991-04-22 | 14 | 0 |
| K911185 | ANTIMICROBIAL AMPICILLIN | Alamar Biosciences Laboratory, Inc. | 1991-04-22 | 35 | 0 |
| K911303 | ANTIMICROBIAL AMIKACIN | Alamar Biosciences Laboratory, Inc. | 1991-04-18 | 24 | 0 |
| K911186 | ANTIMICROBIAL AMPICILLIN/SULBACTAM | Alamar Biosciences Laboratory, Inc. | 1991-04-17 | 30 | 0 |
| K911187 | ANTIMICROBIAL CEFUROXIME | Alamar Biosciences Laboratory, Inc. | 1991-04-17 | 30 | 0 |
| K904689 | ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS | Alamar Biosciences Laboratory, Inc. | 1991-02-07 | 120 | 0 |
| K905853 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1991-02-07 | 51 | 0 |
| K904523 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED | Alamar Biosciences Laboratory, Inc. | 1990-12-21 | 86 | 0 |
| K896965 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1990-01-29 | 45 | 0 |
| K894514 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1989-11-06 | 110 | 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