GGL
8 FDA 510(k) clearances · Product code
67 daysmedian time to decision
426 days90th percentile
8clearances measured
FDA profile
- Official device name
- Control, White-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 |
|---|---|---|
| CD4 COUNT (K083926) | Streck | 2009-02-11 |
| CD-CHEX PLUS BC (K051633) | Streck | 2005-08-16 |
| CD-CHEX CD 34 (K993126) | Streck Laboratories, Inc. | 1999-11-26 |
| CD-CHEX + RBC (K960894) | Streck Laboratories, Inc. | 1996-05-24 |
| CD-CHEX CD4 LOW (K931825) | Streck Laboratories, Inc. | 1994-06-06 |
| CD-CHEX (K920997) | Streck Laboratories, Inc. | 1992-05-31 |
| COULTER POSITIVE CONTROL CELLS (K894651) | Coulter Corp. | 1989-09-13 |
| EDL ABNORMAL COAGULATION CONTROL (K891175) | Elite Diagnostic , Ltd. | 1989-04-10 |
Track GGL automatically
Every clearance here is in the API, with alerts when new ones post.