MDE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dna-Probe, Reagents, Cryptococcal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3165
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST (K903556) | Gen-Probe, Inc. | 1990-10-02 |
Track MDE automatically
Every clearance here is in the API, with alerts when new ones post.