Alamar Biosciences, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Alamar Biosciences, Inc.” (first 1993, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 199 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 3 | 3 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 2 | 2 |
Review panels
- Microbiology (5)
Most recent Alamar Biosciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943756 | MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE | JWY | 1995-02-17 | 199 |
| K944723 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION | JWY | 1994-10-21 | 25 |
| K933885 | ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | JWY | 1993-11-16 | 98 |
| K930478 | READAR | LRG | 1993-10-22 | 266 |
| K925859 | READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS | LRG | 1993-07-08 | 233 |
Recalls
openFDA lists no recalls under a recalling firm named Alamar Biosciences, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
Alamar Biosciences, Inc. (ALMR): EDGAR filings, CIK 2104204. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alamar Biosciences Laboratory, Inc. (26 510(k)s)
- Alamar (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alamar Biosciences, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Alamar Biosciences, Inc.” (first 1993, latest 1995), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alamar Biosciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alamar Biosciences, Inc. is 199 days.
Which FDA product codes appear under Alamar Biosciences, Inc.?
The most frequent FDA product codes under this applicant name are JWY (Manual Antimicrobial Susceptibility Test Systems, 3); LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, 2).
Next steps
- See all 5 Alamar Biosciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Alamar Biosciences, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.