Panels › Hematology › Product code GGL · Class 2
Control, White-Cell
Regulation 864.8625
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GGL
| Company | 510(k)s | Recalls |
|---|---|---|
| Streck Laboratories, Inc. | 4 | 0 |
| Streck | 2 | 0 |
| Coulter Corp. | 1 | 0 |
| Elite Diagnostic , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2009 | K083926 | CD4 COUNT Streck | GGL |
| Aug 16, 2005 | K051633 | CD-CHEX PLUS BC Streck | GGL |
| Nov 26, 1999 | K993126 | CD-CHEX CD 34 Streck Laboratories, Inc. | GGL |
| May 24, 1996 | K960894 | CD-CHEX + RBC Streck Laboratories, Inc. | GGL |
| Jun 6, 1994 | K931825 | CD-CHEX CD4 LOW Streck Laboratories, Inc. | GGL |
| May 31, 1992 | K920997 | CD-CHEX Streck Laboratories, Inc. | GGL |
| Sep 13, 1989 | K894651 | COULTER POSITIVE CONTROL CELLS Coulter Corp. | GGL |
| Apr 10, 1989 | K891175 | EDL ABNORMAL COAGULATION CONTROL Elite Diagnostic , Ltd. | GGL |
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