GGW · Class II · 21 CFR 864.7925

FDA Product Code GGW: Test, Time, Partial Thromboplastin

Leading manufacturers include American Bioproducts Co., Bio/Data Corp. and Helena Laboratories.

32
Total
32
Cleared
117d
Avg days
1979
Since
32 devices
25–32 of 32
Cleared Jul 16, 1981
ACTIN FS ACTIVATED PTT REAGENT
K811589
American Dade
Hematology · 38d
Cleared Nov 12, 1980
AB-TROL COAGULATION CONTROL
K802232
Helena Laboratories
Hematology · 58d
Cleared Sep 09, 1980
HEP-TROL
K801932
Helena Laboratories
Hematology · 28d
Cleared Jul 28, 1980
PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT
K801460
Pacific Hemostasis
Hematology · 34d
Cleared Jul 21, 1980
VERIFY S PROD. #34141
K800925
General Diagnostics
Hematology · 91d
Cleared Jul 14, 1980
ANTIBODY TO VARICELLA-ZOSTER VIRUS
K800787
Electro-Nucleonics Laboratories, Inc.
Microbiology · 97d
Cleared Jun 04, 1980
A-GENT QUANTICHROM THROMBIGEN I
K800725
Abbott Laboratories
Hematology · 64d
Cleared Nov 05, 1979
LANCER COAGENT APTT KIT
K792048
Sherwood Medical Co.
Hematology · 24d