Alamar Biosciences Laboratory, Inc.: FDA clearances and approvals
Alamar Biosciences Laboratory, Inc. has 26 FDA 510(k) clearances (first 1989, latest 1994), across 4 product codes in 1 review panel. Median 510(k) review time: 62 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 22 | 22 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 2 | 2 |
| JSS | Kit, Identification, Enterobacteriaceae | 1 | 1 |
| LRH | Instrument For Auto Reader Of Overnight Microorganism Identification System | 1 | 1 |
Review panels
- Microbiology (26)
Most recent Alamar Biosciences Laboratory, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941425 | ALAMAR ANTIBIOTIC SUSCEPTIBILITY | LRG | 1994-12-15 | 267 |
| K926248 | READER | LRH | 1994-05-17 | 519 |
| K926002 | ALAMAR BACTERIAL IDENTIFICATION TEST PANEL | JSS | 1993-09-23 | 300 |
| K925951 | READAR | LRG | 1993-08-31 | 280 |
| K930469 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | JWY | 1993-06-25 | 148 |
| K930055 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | JWY | 1993-04-05 | 89 |
| K924500 | ANTIMICROBIAL SUSCEPTIBILITY TEST | JWY | 1992-11-30 | 87 |
| K922780 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | JWY | 1992-08-20 | 72 |
| K922003 | ANTIMICROBIAL SUSCETIBILITY TEST PANEL | JWY | 1992-08-19 | 112 |
| K922168 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | JWY | 1992-07-28 | 81 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alamar Biosciences Laboratory, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Alamar Biosciences Laboratory, Inc. have?
Alamar Biosciences Laboratory, Inc. has 26 FDA 510(k) clearances (first 1989, latest 1994), across 4 product codes in 1 review panel.
How long does FDA take to clear Alamar Biosciences Laboratory, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Alamar Biosciences Laboratory, Inc.'s cleared 510(k)s is 62 days.
What devices does Alamar Biosciences Laboratory, Inc. make?
Its most frequent FDA product codes are JWY (Manual Antimicrobial Susceptibility Test Systems, 22); LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, 2); JSS (Kit, Identification, Enterobacteriaceae, 1).
Has Alamar Biosciences Laboratory, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Alamar Biosciences Laboratory, Inc. Related entities may recall under other names.
Next steps
- See all 26 Alamar Biosciences Laboratory, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Alamar Biosciences Laboratory, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.