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 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
Cleared Feb 07, 1977
QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT
K761058
Bio/Data Corp.
Hematology · 81d