JST
6 FDA 510(k) clearances · Product code
46 daysmedian time to decision
99 days90th percentile
6clearances measured
FDA profile
- Official device name
- Kit, Fastidious Organisms
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2017: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM (K962423) | Becton Dickinson Microbiology Systems | 1996-08-02 |
| API 50 CHB (CULTURE MEDIA) (K854732) | Dms Products, Inc. | 1986-03-04 |
| SYNTHETIC BROTH A.O.A.C. (K841661) | Oxoid U.S.A., Inc. | 1984-05-11 |
| RIM-HAEMOPHILUS 2 (K832239) | Austin Biological Laboratories | 1983-08-12 |
| RIM-HAEMOPHILUS 1 & 2 (K832051) | Austin Biological Laboratories | 1983-08-12 |
| STREPTOCOCUS ID PLATE (K831349) | Granite Diagnostics, Inc. | 1983-05-16 |
Track JST automatically
Every clearance here is in the API, with alerts when new ones post.