GGL · Class II · 21 CFR 864.8625

FDA Product Code GGL: Control, White-cell

Leading manufacturers include Streck Laboratories, Inc., Streck and Elite Diagnostic , Ltd..

8
Total
8
Cleared
106d
Avg days
1989
Since

FDA 510(k) Cleared Control, White-cell Devices (Product Code GGL)

8 devices
1–8 of 8
Cleared Feb 11, 2009
CD4 COUNT
K083926
Streck
Hematology · 42d
Cleared Aug 16, 2005
CD-CHEX PLUS BC
K051633
Streck
Hematology · 57d
Cleared Nov 26, 1999
CD-CHEX CD 34
K993126
Streck Laboratories, Inc.
Hematology · 67d
Cleared May 24, 1996
CD-CHEX + RBC
K960894
Streck Laboratories, Inc.
Hematology · 80d
Cleared Jun 06, 1994
CD-CHEX CD4 LOW
K931825
Streck Laboratories, Inc.
Hematology · 426d
Cleared May 31, 1992
CD-CHEX
K920997
Streck Laboratories, Inc.
Hematology · 90d
Cleared Sep 13, 1989
COULTER POSITIVE CONTROL CELLS
K894651
Coulter Corp.
Hematology · 51d
Cleared Apr 10, 1989
EDL ABNORMAL COAGULATION CONTROL
K891175
Elite Diagnostic , Ltd.
Hematology · 35d

About Product Code GGL - Regulatory Context