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 Oct 19, 1992
PLATELIN L
K921396
Organon Teknika Corp.
Hematology · 210d
Cleared Aug 18, 1992
ACS FREEZE-DRIED APTT REAGENT
K921223
Analytical Control Systems, Inc.
Hematology · 158d
Cleared Jul 28, 1992
ACS APCT REAGENT
K921118
Analytical Control Systems, Inc.
Hematology · 141d
Cleared Feb 14, 1992
ELLAGIC ACID APTT REAGENT
K915418
Helena Laboratories
Hematology · 74d
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 Jan 25, 1991
ANTICARDIOLIPIN ANTIBODY TEST SYSTEM
K903531
Medical Innovations Corp.
Immunology · 172d
Cleared Jan 14, 1991
THE THERATEST ACA TEST
K905301
Theratest Laboratories, Inc.
Immunology · 48d
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 Jun 22, 1989
APTT BY HEMOCHRON(R)
K892209
Intensive Technology, Inc.
Hematology · 80d
Cleared May 22, 1989
COAG-1 APTT TEST CARD
K891015
Cardiovascular Diagnostic Services
Hematology · 83d
Cleared Apr 21, 1989
EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME
K890859
Elite Diagnostic , Ltd.
Hematology · 59d
Cleared Apr 21, 1989
THROMBOSCREEN APTT REAGENT
K891337
Pacific Hemostasis
Hematology · 42d
Cleared Mar 15, 1989
EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K890619
Elite Diagnostic , Ltd.
Hematology · 36d
Cleared Feb 24, 1989
BIOTRACK APTT REAGENT CARTRIDGE
K890052
Biotrack, Inc.
Hematology · 49d
Cleared Jan 30, 1989
APTT REAGENT
K884856
Precision Biologicals, Inc.
Hematology · 73d
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 Mar 23, 1988
CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K881068
Creative Laboratory Products, Inc.
Hematology · 9d