FDA.report

510(k) K213464

Device
HemosIL Liquid Anti-Xa
Applicant
Instrumentation Laboratory CO
510(k) number
K213464
Product code
KFF
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-04
Date received
2021-10-28
Regulation
864.7525
Classification name
Assay, Heparin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Carol Marble
Address
180 Hartwell Rd. Bedford MA US 01730 01730

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code KFF

510(k)DeviceApplicantDecision date
K162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbH2017-08-22
K111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.2011-10-26
K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory CO2009-06-02
K050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen Biomed2006-05-24
K013305ENOXAPARIN TEST CARDCardiovascular Diagnostics, Inc.2002-08-23
K013637ACTICHROME HEPARIN (ANTI-FIIA)American Diagnostica, Inc.2002-04-16
K013318ACTICHROME HEPARIN (ANTI-FXA), MODEL 832American Diagnostica, Inc.2002-03-08
K010455ROTACHROM HEPARIN AND STA -ROTACHROM HEPARINDiagnostica-Stago2001-06-07
K010193HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYSInternational Technidyne Corp.2001-06-06
K983178COAMATIC HEPARINInstrumentation Laboratory CO1998-11-03
K980242IL TEST HEPARINInstrumentation Laboratory CO1998-03-19
K972209SPECTROLYSE HEPARIN (ANTI-IIA)Medical Diagnostic Technologies, Inc.1997-08-12
K965076MDA HEPARIN ANTI-X ASSAYOrganon Teknika Corp.1997-03-18
K952667CHROM Z-HEPARIN, CAT. NO 5242Helena Laboratories1996-02-14
K952514COACUTE HEPARINChromogenix AB1995-11-20