FDA Product Code
FDA Product Code GLQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8625
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111211 | CELL-DYN 22 PLUS CONTROL | Streck | 2011-12-22 | Traditional | PDF ↗ |
| K110718 | CELL-CHEX WITH CPPD CRYSTALS | Streck | 2011-05-26 | Traditional | PDF ↗ |
| K101335 | CELL-CHEX | Streck | 2010-08-23 | Traditional | PDF ↗ |
| K090137 | STAK-CHEX PLUS RETICS | Streck | 2009-03-18 | Traditional | PDF ↗ |
| K000945 | PARA 12 PLUS RETICS | Streck Laboratories, Inc. | 2000-04-18 | Traditional | PDF ↗ |
| K994388 | XE CHECK | Streck Laboratories, Inc. | 2000-01-14 | Traditional | PDF ↗ |
| K992887 | STAK-CHEX PLUS RETICS | Streck Laboratories, Inc. | 1999-11-22 | Traditional | PDF ↗ |
| K823794 | CONTROL TM 8 | General Diagnostics | 1983-01-14 | Traditional | PDF ↗ |
| K823587 | UNI-CELL | Medical Specialties Laboratories | 1983-01-05 | Traditional | PDF ↗ |
| K823498 | PARA 12 | Streck Laboratories, Inc. | 1982-12-28 | Traditional | PDF ↗ |
Product code GLQ · Class II · Hematology. Data: openFDA.