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 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 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