JSY
5 FDA 510(k) clearances · Product code
259 daysmedian time to decision
259 days90th percentile
5clearances measured
FDA profile
- Official device name
- Kit, Identification, Mycobacteria
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MYCOAKT M. AVIUM CULTURE ID KIT (K943049) | Dynagen, Inc. | 1995-03-13 |
| MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT (K943051) | Dynagen, Inc. | 1995-03-13 |
| MYCOAKT M KANSASII CULTURE ID KIT (K943050) | Dynagen, Inc. | 1995-03-13 |
| ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION (K880990) | Alpha-Tec Systems, Inc. | 1988-03-24 |
| API TB-IDENT* (K830211) | Analytical Products, Inc. | 1983-03-24 |
Track JSY automatically
Every clearance here is in the API, with alerts when new ones post.