FDA Product Code KFF: Assay, Heparin
Leading manufacturers include Instrumentation Laboratory CO, E.I. Dupont DE Nemours & Co., Inc. and Helena Laboratories.
46
Total
46
Cleared
206d
Avg days
1979
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Assay, Heparin Devices (Product Code KFF)
46 devices
Cleared
Oct 04, 2022
HemosIL Liquid Anti-Xa
Instrumentation Laboratory CO
Hematology
341d
Cleared
Jun 02, 2009
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
Instrumentation Laboratory CO
Hematology
125d
Cleared
Nov 03, 1998
COAMATIC HEPARIN
Instrumentation Laboratory CO
Hematology
53d
Cleared
Mar 19, 1998
IL TEST HEPARIN
Instrumentation Laboratory CO
Hematology
55d
Cleared
Feb 14, 1996
CHROM Z-HEPARIN, CAT. NO 5242
Helena Laboratories
Hematology
247d
Cleared
Feb 07, 1994
IL TEST HEPARIN (XA), PN 84699-15
Instrumentation Laboratory CO
Hematology
101d
Cleared
Jan 05, 1987
IL TEST 97575-15, HEPARIN ASSAY
Instrumentation Laboratory CO
Hematology
69d
Cleared
Nov 30, 1984
HEPARIN ACA ANALYTICAL TEST PACK
E.I. Dupont DE Nemours & Co., Inc.
Hematology
108d
Cleared
Nov 30, 1984
HEPARIN CALIBRATOR ACA
E.I. Dupont DE Nemours & Co., Inc.
Hematology
108d
About Product Code KFF - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code KFF since 1979, with 46 receiving FDA clearance (average review time: 206 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.