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
49–72 of 190
Cleared Jan 05, 1987
COAGULATION EXTRINSIC DEFICIENT PLASMAS
K864497
Instrumentation Laboratory CO
Hematology · 52d
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
Cleared Nov 19, 1984
FACTOR IX DEFICIENT PLASMA, B9D -
K843215
Sigma Chemical Co.
Hematology · 96d
Cleared Nov 19, 1984
FACTOR X DEFICIENT PLASMA, BLOD HUMAN
K843310
Sigma Chemical Co.
Hematology · 88d
Cleared Nov 19, 1984
FACTOR XI DEFICIENT PLASMA B11D
K843438
Sigma Chemical Co.
Hematology · 76d
Cleared Nov 19, 1984
FACTOR XII DEFICIENT PLASMA B12D
K843451
Sigma Chemical Co.
Hematology · 75d
Cleared Apr 05, 1984
RISTOCETIN COFACTOR ASSAY
K840329
Helena Laboratories
Hematology · 71d
Cleared Dec 16, 1983
FACTOR II DEFICIENT SUBSTRATE PLASMA
K834031
Helena Laboratories
Hematology · 24d
Cleared Dec 28, 1982
FACTOR VIII RELATED ANTIGEN ROCKET EID
K823267
Helena Laboratories
Hematology · 56d
Cleared Sep 23, 1981
FACTOR VIII DEFICIENT PLASMA #B8D
K812431
Sigma Chemical Co.
Hematology · 29d
Cleared Jan 24, 1980
HELENA FACTOR XII DEFICIENT
K792656
Helena Laboratories
Hematology · 29d
Cleared Dec 31, 1979
HELENA FACTOR IX DEFICIENT SUBSTRATE
K792475
Helena Laboratories
Hematology · 28d
Cleared Dec 31, 1979
HELENA FACTOR XI DEFICIENT SUBSTRATE
K792476
Helena Laboratories
Hematology · 28d
Cleared Dec 31, 1979
HELENA FACTOR V DEFICIENT SUBSTRATE
K792507
Helena Laboratories
Hematology · 27d
Cleared Dec 31, 1979
HELENA FACTOR X DEFICIENT SUBSTRATE
K792508
Helena Laboratories
Hematology · 27d
Cleared Dec 31, 1979
HELENA FACTOR VII DEFICIENT SUB. PLASMA
K792511
Helena Laboratories
Hematology · 26d
Cleared Dec 27, 1979
HELENA FACTOR II DEFICIENT SUB. PLASMA
K792336
Helena Laboratories
Hematology · 38d
Cleared Dec 04, 1979
HELENA FACTOR VIII DEFICIENT SUB. PLASMA
K792335
Helena Laboratories
Hematology · 15d
Cleared Oct 01, 1979
FACTOR VII DEFICIENT PLASMA
K791794
Sigma Chemical Co.
Hematology · 18d
Cleared Apr 04, 1979
FACTOR V DEFICIENT
K790423
Sigma Chemical Co.
Hematology · 34d