GGP · Class II · 21 CFR 864.7290

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

Leading manufacturers include Instrumentation Laboratory CO, Helena Laboratories and Sigma Chemical Co..

190
Total
190
Cleared
108d
Avg days
1977
Since
190 devices
25–48 of 190
Cleared Sep 28, 1998
COAMATIC PLASMIN INHIBITOR
K981817
Instrumentation Laboratory CO
Hematology · 129d
Cleared Aug 27, 1998
IL TEST PLASMIN INHIBITOR
K981696
Instrumentation Laboratory CO
Hematology · 105d
Cleared May 26, 1998
IL TEST PLASMINOGEN
K981200
Instrumentation Laboratory CO
Hematology · 54d
Cleared May 01, 1998
COAMATIC PLASMINOGEN
K974711
Instrumentation Laboratory CO
Hematology · 135d
Cleared Apr 21, 1998
IL TEST PROTEIN C
K980875
Instrumentation Laboratory CO
Hematology · 46d
Cleared Apr 16, 1998
COAMATIC FACTOR VIII
K981038
Instrumentation Laboratory CO
Hematology · 28d
Cleared Feb 09, 1996
CHROM Z-F:VIII, CAT. NO. 5241
K952668
Helena Laboratories
Hematology · 242d
Cleared Jan 30, 1996
CHROM Z-PROTEIN C, CAT. NO. 5243
K952666
Helena Laboratories
Hematology · 232d
Cleared Dec 07, 1995
CHROM Z-PLASMINOGEN, CAT. NO. 5244
K952669
Helena Laboratories
Hematology · 178d
Cleared Apr 12, 1993
IL TEST(TM) PROTEIN S
K930327
Instrumentation Laboratory CO
Hematology · 80d
Cleared Jan 14, 1993
IL TEST(TM) PRO-CHROM
K924884
Instrumentation Laboratory CO
Hematology · 108d
Cleared Aug 12, 1992
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
K920012
Instrumentation Laboratory CO
Hematology · 223d
Cleared Oct 09, 1991
IL TEST PROCLOT ASSAY STYSTEM
K912711
Instrumentation Laboratory CO
Hematology · 112d
Cleared Feb 26, 1991
DADE PROTEIN C CLOTTING ASSAY
K903468
Baxter Healthcare Corp
Hematology · 209d
Cleared Jan 18, 1991
FREE PROTEIN S REAGENT CAT. NO. 5363
K904247
Helena Laboratories
Hematology · 126d
Cleared Mar 15, 1990
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
K896174
Helena Laboratories
Hematology · 141d
Cleared Feb 05, 1990
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
K897136
Helena Laboratories
Hematology · 40d
Cleared Feb 27, 1989
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY
K890409
Baxter Healthcare Corp
Hematology · 34d
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 Feb 09, 1988
CALIBRATION REFERENCE PLASMA
K874940
Baxter Healthcare Corp
Hematology · 69d
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