KFF · Class II · 21 CFR 864.7525

FDA Product Code KFF: Assay, Heparin

Leading manufacturers include American Bioproducts Co., Instrumentation Laboratory CO and International Technidyne Corp..

46
Total
46
Cleared
206d
Avg days
1979
Since
46 devices
25–46 of 46
Cleared Mar 15, 1990
ORTHOKROME* HEPARIN
K900396
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Jan 05, 1987
IL TEST 97575-15, HEPARIN ASSAY
K864211
Instrumentation Laboratory CO
Hematology · 69d
Cleared Mar 03, 1986
HEPANORM CALIBRATION PLASMA SET
K854762
American Bioproducts Co.
Hematology · 96d
Cleared May 08, 1985
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
K850486
Warner-Lambert Co.
Hematology · 90d
Cleared Nov 30, 1984
HEPARIN ACA ANALYTICAL TEST PACK
K843201
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 108d
Cleared Nov 30, 1984
HEPARIN CALIBRATOR ACA
K843202
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 108d
Cleared Sep 29, 1983
DIACROM * HEPARIN
K832373
Wellcome Diagnostics
Chemistry · 73d
Cleared Oct 02, 1981
CI-TROL HEPARIN CONTROLS, LOW/HIGH
K812424
American Dade
Hematology · 39d
Cleared Feb 15, 1979
HEPARIN ASSAY
K781479
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 171d