GFO · Class II · 21 CFR 864.7925

FDA Product Code GFO: Activated Partial Thromboplastin

Leading manufacturers include Analytical Control Systems, Inc., International Technidyne Corp. and Instrumentation Laboratory CO.

52
Total
52
Cleared
100d
Avg days
1976
Since
52 devices
49–52 of 52
Cleared Apr 26, 1982
ALUMINA SILICA-ACTIVATED PARTIAL THROM
K820835
Hyland Therapeutic Div., Travenol Laboratories
Hematology · 31d
Cleared Aug 10, 1978
PLASMA COAGULATION CONT., ABNORMAL
K781104
Ortho Diagnostics, Inc.
Hematology · 38d
Cleared Jan 10, 1977
HEPARIN CONTROL PLASMA
K760918
Hyland Therapeutic Div., Travenol Laboratories
Hematology · 74d
Cleared Aug 03, 1976
ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT
K760318
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 8d