ClearanceBrief
Panels › Hematology › Product code KFF · Class 2

Assay, Heparin

Regulation 864.7525

1510(k)s in 12 months (47 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
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Top companies in KFF

Company510(k)sRecalls
Instrumentation Laboratory CO67
American Bioproducts Co.80
Diagnostica Stago, Inc.33
International Technidyne Corp.21
American Diagnostica, Inc.20
Cardiovascular Diagnostics, Inc.20
E.I. Dupont DE Nemours & Co., Inc.20
Organon Teknika Corp.20
American Dade10
Behring Diagnostics, Inc.10
DateFirm and productCodeLinked 510(k)
Aug 28, 2025Diagnostica Stago, Inc.
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the
Open, Classified		 KFFK111822
Aug 28, 2025Diagnostica Stago, Inc.
STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the
Open, Classified		 KFFK111822
Aug 13, 2025Instrumentation Laboratory
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Open, Classified		 KFFK213464
K980242
Jan 24, 2025Instrumentation Laboratory
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Open, Classified		 KFFK213464
Sep 30, 2024Instrumentation Laboratory
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
Open, Classified		 KFFK090209
Sep 30, 2024Instrumentation Laboratory
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
Open, Classified		 KFFK090209
Sep 30, 2024Instrumentation Laboratory
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
Open, Classified		 KFFK090209
Sep 30, 2024Instrumentation Laboratory
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
Open, Classified		 KFFK090209
Aug 25, 2021Instrumentation Laboratory
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL C
Open, Classified		 KFFK090209
Sep 16, 2014Diagnostica Stago, Inc.
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma l
Terminated		 KFFK111822
Jul 28, 2010International Technidyne Corp.
RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood - 2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blo
Terminated		 KFFK904003
Jul 31, 2004Dade Behring , Inc.
Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
Terminated		 KFFNone listed

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