GLQ
10 FDA 510(k) clearances · Product code
56 daysmedian time to decision
237 days90th percentile
10clearances measured
FDA profile
- Official device name
- Mixture, Control, White-Cell And Red-Cell Indices
- 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 |
|---|---|---|
| CELL-DYN 22 PLUS CONTROL (K111211) | Streck | 2011-12-22 |
| CELL-CHEX WITH CPPD CRYSTALS (K110718) | Streck | 2011-05-26 |
| CELL-CHEX (K101335) | Streck | 2010-08-23 |
| STAK-CHEX PLUS RETICS (K090137) | Streck | 2009-03-18 |
| PARA 12 PLUS RETICS (K000945) | Streck Laboratories, Inc. | 2000-04-18 |
| XE CHECK (K994388) | Streck Laboratories, Inc. | 2000-01-14 |
| STAK-CHEX PLUS RETICS (K992887) | Streck Laboratories, Inc. | 1999-11-22 |
| CONTROL TM 8 (K823794) | General Diagnostics | 1983-01-14 |
| UNI-CELL (K823587) | Medical Specialties Laboratories | 1983-01-05 |
| PARA 12 (K823498) | Streck Laboratories, Inc. | 1982-12-28 |
Track GLQ automatically
Every clearance here is in the API, with alerts when new ones post.