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 Jun 11, 1991
DADE(R) PROTEIN C ABNORMAL CONTRAL
K911885
Baxter Healthcare Corp
Hematology · 43d
Cleared Oct 22, 1990
COAGULATION REFERENCE PLASMA, ABNORMAL
K904073
Medi-Tech, Inc.
Hematology · 47d
Cleared Apr 11, 1990
ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
K901233
Ortho Diagnostic Systems, Inc.
Hematology · 28d
Cleared Mar 27, 1990
HEPARIN CONTROL PLASMA, FOR USE IN APTT
K900782
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Oct 06, 1989
ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)
K895260
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Oct 06, 1989
ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)
K895261
Medical Diagnostic Technologies, Inc.
Hematology · 45d
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 May 06, 1988
CLP ABNORMAL COAGULATION CONTROL
K881510
Creative Laboratory Products, Inc.
Hematology · 25d
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