GGLClass II
Control, White-cell
Hematology · 21 CFR 864.8625
MDR events1All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances8All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- StreckFeb 11, 2009
K083926 · CD4 COUNT
- StreckAug 16, 2005
K051633 · CD-CHEX PLUS BC
- Streck Laboratories, Inc.Nov 26, 1999
K993126 · CD-CHEX CD 34
- Streck Laboratories, Inc.May 24, 1996
K960894 · CD-CHEX + RBC
- Streck Laboratories, Inc.Jun 6, 1994
K931825 · CD-CHEX CD4 LOW
- Streck Laboratories, Inc.May 31, 1992
K920997 · CD-CHEX
- Coulter Corp.Sep 13, 1989
K894651 · COULTER POSITIVE CONTROL CELLS
- Elite Diagnostic , Ltd.Apr 10, 1989
K891175 · EDL ABNORMAL COAGULATION CONTROL