Akers Biosciences, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Akers Biosciences, Inc.” (first 2005, latest 2011), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| DJZ | Devices, Breath Trapping, Alcohol | 3 | 3 |
| GGN | Plasma, Coagulation Control | 1 | 1 |
| JIH | Flame Photometry, Lithium | 1 | 1 |
Review panels
- Clinical Toxicology (4)
- Hematology (1)
Most recent Akers Biosciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102338 | BREATHSCN PRO | DJZ | 2011-01-12 | 147 |
| K062971 | BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS | DJZ | 2006-12-18 | 80 |
| K060761 | BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS | DJZ | 2006-04-28 | 38 |
| K052697 | HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL | GGN | 2006-01-04 | 98 |
| K050338 | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM | JIH | 2005-03-04 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Akers 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.
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.
- Akers Laboratories, Inc. (3 510(k)s)
- Akers Research Corp. (3 510(k)s)
- Akers Medical Technologies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Akers Biosciences, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Akers Biosciences, Inc.” (first 2005, latest 2011), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Akers Biosciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Akers Biosciences, Inc. is 80 days.
Which FDA product codes appear under Akers Biosciences, Inc.?
The most frequent FDA product codes under this applicant name are DJZ (Devices, Breath Trapping, Alcohol, 3); GGN (Plasma, Coagulation Control, 1); JIH (Flame Photometry, Lithium, 1).
Next steps
- See all 5 Akers Biosciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DJZ, Akers 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.