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
25–48 of 52
Cleared Feb 11, 1992
HEMOCHRON ONESTEP APTT TEST
K915344
International Technidyne Corp.
Hematology · 77d
Cleared Jul 17, 1991
HEMOCHRON(R) APTT, MODIFICATION
K911994
International Technidyne Corp.
Hematology · 86d
Cleared Nov 08, 1990
APTT REAGENT
K904341
Sigma Chemical Co.
Hematology · 49d
Cleared Aug 06, 1990
ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K902556
Analytical Control Systems, Inc.
Hematology · 59d
Cleared Jan 25, 1990
APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT
K900049
Medical Diagnostic Technologies, Inc.
Hematology · 22d
Cleared Dec 01, 1989
ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
K896545
Sigma Chemical Co.
Hematology · 14d
Cleared Oct 06, 1989
APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT
K895255
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jan 27, 1989
EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629
K884702
Em Diagnostic Systems, Inc.
Hematology · 79d
Cleared Dec 28, 1988
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K884485
King Diagnostics, Inc.
Hematology · 64d
Cleared Aug 25, 1988
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K882325
Sclavo, Inc.
Hematology · 80d
Cleared Apr 26, 1982
ALUMINA SILICA-ACTIVATED PARTIAL THROM
K820835
Hyland Therapeutic Div., Travenol Laboratories
Hematology · 31d
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