GJR
5 FDA 510(k) clearances · Product code
36 daysmedian time to decision
371 days90th percentile
5clearances measured
FDA profile
- Official device name
- Control, Red-Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NRBC-CHEX FOR ADVIA (K080016) | Streck | 2008-02-05 |
| NRBC-CHEX FOR LH (K060083) | Streck | 2006-02-09 |
| CELL-CHEX (K000076) | Streck Laboratories, Inc. | 2000-03-03 |
| SEDRATROL (K940430) | Medical Specialties Intl., Inc. | 1995-02-06 |
| RET-CHECK (K900484) | Streck Laboratories, Inc. | 1990-03-09 |
Track GJR automatically
Every clearance here is in the API, with alerts when new ones post.