GRO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antisera, Fluorescent, All Types, Hemophilus Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3300
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LEGIONELLA CULTURE CONFIRMATIN KIT (K851271) | Gen-Probe, Inc. | 1985-07-08 |
| LEGIONELLA DIFFERENTIATION DISK (K834067) | Remel Co. | 1984-01-03 |
| PHADEBACT HAEMOPHILUS TEST (K802423) | Pharmacia, Inc. | 1980-11-12 |
| BACTOGEN-H. INFLUENZAE TYPE B (K800493) | Armkel, LLC | 1980-04-04 |
Track GRO automatically
Every clearance here is in the API, with alerts when new ones post.