Dynagen, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dynagen, Inc.” (first 1992, latest 1996), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 248 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 |
|---|---|---|---|
| JSY | Kit, Identification, Mycobacteria | 3 | 3 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| MIG | Strip, Test Isoniazid | 1 | 1 |
| MRS | Test System, Nicotine, Cotinine, Metabolites | 1 | 1 |
Review panels
- Microbiology (3)
- Clinical Toxicology (3)
Most recent Dynagen, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963733 | NICCHECK I | MRS | 1996-12-13 | 88 |
| K943051 | MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT | JSY | 1995-03-13 | 259 |
| K943050 | MYCOAKT M KANSASII CULTURE ID KIT | JSY | 1995-03-13 | 259 |
| K943049 | MYCOAKT M. AVIUM CULTURE ID KIT | JSY | 1995-03-13 | 259 |
| K931105 | PROCHECK(TM) BLIND PERFORMANCE SPECIMENS | DIF | 1993-04-21 | 49 |
| K912888 | URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL | MIG | 1992-02-24 | 238 |
Recalls
openFDA lists no recalls under a recalling firm named Dynagen, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dynagen, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Dynagen, Inc.” (first 1992, latest 1996), across 4 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 Dynagen, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dynagen, Inc. is 248 days.
Which FDA product codes appear under Dynagen, Inc.?
The most frequent FDA product codes under this applicant name are JSY (Kit, Identification, Mycobacteria, 3); DIF (Drug Mixture Control Materials, 1); MIG (Strip, Test Isoniazid, 1).
Next steps
- See all 6 Dynagen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSY, Dynagen, 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.