GGC · Class II · 21 CFR 864.5425

FDA Product Code GGC: Control, Plasma, Abnormal

Leading manufacturers include American Bioproducts Co., Analytical Control Systems, Inc. and Medical Diagnostic Technologies, Inc..

40
Total
40
Cleared
121d
Avg days
1977
Since
40 devices
25–40 of 40
Cleared Aug 03, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
K894425
Analytical Control Systems, Inc.
Hematology · 17d
Cleared Jul 25, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
K893970
Analytical Control Systems, Inc.
Hematology · 53d
Cleared Jul 25, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
K893971
Analytical Control Systems, Inc.
Hematology · 53d
Cleared Jul 25, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III
K894338
Analytical Control Systems, Inc.
Hematology · 11d
Cleared Dec 11, 1987
HERPES 1 AND 2 MICROASSAYS
K871420
Diamedix Corp.
Microbiology · 247d
Cleared Feb 18, 1977
HPC TM (HEPARINIZED PLASMA CONTROL)
K770188
Bio/Data Corp.
Hematology · 21d