GGP · Class II · 21 CFR 864.7290

FDA Product Code GGP: Test, Qualitative And Quantitative Factor Deficiency

Leading manufacturers include Instrumentation Laboratory CO, American Bioproducts Co. and Helena Laboratories.

190
Total
190
Cleared
108d
Avg days
1977
Since
190 devices
121–144 of 190
Cleared Feb 02, 1989
DADE PROTEIN C CHROMOGENIC ASSAY
K884881
Baxter Healthcare Corp
Hematology · 72d
Cleared Dec 30, 1988
DADE FACTOR VIII CHROMOGENIC ASSAY
K884544
Baxter Healthcare Corp
Hematology · 60d
Cleared Dec 30, 1988
DADE FACTOR IX CHROMOGENIC ASSAY
K884551
Baxter Healthcare Corp
Hematology · 60d
Cleared Dec 13, 1988
COATEST PROTEIN C
K884058
Kabivitrum, Inc.
Hematology · 78d
Cleared Sep 02, 1988
STACHROM ANTIPLASMIN TEST KIT
K882602
American Bioproducts Co.
Hematology · 70d
Cleared Sep 02, 1988
STACHROM ANTIPLASMIN CONTROL
K882603
American Bioproducts Co.
Hematology · 70d
Cleared Jul 01, 1988
SPECTROLYSE/FIBRIN
K881037
Cytrx Biopool, Ltd.
Hematology · 112d
Cleared Feb 09, 1988
CALIBRATION REFERENCE PLASMA
K874940
Baxter Healthcare Corp
Hematology · 69d
Cleared Dec 03, 1987
STACHROM VIII:C TEST KIT
K874097
American Bioproducts Co.
Hematology · 56d
Cleared Sep 04, 1987
SPECTRO C
K872941
Ramco Laboratories, Inc.
Hematology · 39d
Cleared Aug 21, 1987
ASSERACHROM PROTEIN S TEST KIT
K872479
American Bioproducts Co.
Hematology · 59d
Cleared May 21, 1987
STACHROM PROTEIN C TEST KIT
K871039
American Bioproducts Co.
Hematology · 65d
Cleared Apr 23, 1987
PROTEIN S CONTROL PLASMA
K870917
American Bioproducts Co.
Hematology · 48d
Cleared Mar 30, 1987
VWF IMMUNOBLOT
K864701
Ramco Laboratories, Inc.
Hematology · 118d
Cleared Feb 10, 1987
IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)
K870353
American Dade
Hematology · 12d
Cleared Feb 10, 1987
IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)
K870354
American Dade
Hematology · 12d
Cleared Jan 21, 1987
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
K864480
Instrumentation Laboratory CO
Hematology · 69d
Cleared Jan 05, 1987
COAGULATION INTRINSIC DEFICIENT PLASMAS
K864481
Instrumentation Laboratory CO
Hematology · 53d
Cleared Jan 05, 1987
COAGULATION EXTRINSIC DEFICIENT PLASMAS
K864497
Instrumentation Laboratory CO
Hematology · 52d
Cleared Jun 25, 1986
ASSERA-PLATE VWF KIT
K861417
American Bioproducts Co.
Hematology · 71d
Cleared Jun 25, 1986
ASSERA-PLATE PROTEIN C KIT
K861475
American Bioproducts Co.
Hematology · 64d
Cleared Jun 19, 1986
STACLOT PROTEIN C TEST KIT
K861079
American Bioproducts Co.
Hematology · 90d
Cleared May 29, 1986
PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
K861048
Sigma Chemical Co.
Hematology · 71d
Cleared May 29, 1986
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
K861049
Sigma Chemical Co.
Hematology · 71d