FDA.reportPublic FDA data

510(k) K935212

Device
IL TEST HEPARIN (XA), PN 84699-15
Applicant
Instrumentation Laboratory CO
510(k) number
K935212
Product code
KFF
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-07
Date received
1993-10-29
Regulation
864.7525
Classification name
Assay, Heparin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
WALLIS W CADY
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), Device, Applicant table
510(k)DeviceApplicantDecision date
K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO2022-10-04
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