FDA Product Code
FDA Product Code GGL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8625
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K083926 | CD4 COUNT | Streck | 2009-02-11 | Traditional | PDF ↗ |
| K051633 | CD-CHEX PLUS BC | Streck | 2005-08-16 | Traditional | PDF ↗ |
| K993126 | CD-CHEX CD 34 | Streck Laboratories, Inc. | 1999-11-26 | Traditional | PDF ↗ |
| K960894 | CD-CHEX + RBC | Streck Laboratories, Inc. | 1996-05-24 | Traditional | PDF ↗ |
| K931825 | CD-CHEX CD4 LOW | Streck Laboratories, Inc. | 1994-06-06 | Traditional | PDF ↗ |
| K920997 | CD-CHEX | Streck Laboratories, Inc. | 1992-05-31 | Traditional | PDF ↗ |
| K894651 | COULTER POSITIVE CONTROL CELLS | Coulter Corp. | 1989-09-13 | Traditional | PDF ↗ |
| K891175 | EDL ABNORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | 1989-04-10 | Traditional | PDF ↗ |
Product code GGL · Class II · Hematology. Data: openFDA.