FDA.report

510(k) K243374

Device
HemosIL CL HIT-IgG(PF4-H)
Applicant
Instrumentation Laboratory (IL) Co.
510(k) number
K243374
Product code
LCO
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-28
Date received
2024-10-30
Regulation
864.7695
Classification name
Platelet Factor 4 Radioimmunoassay
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Nikita Malladi
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 LCO

510(k)DeviceApplicantDecision date
K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc.2020-09-11
K201311PF4 IgG assayImmucor Gti Diagnostics, Inc.2020-06-18
K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO2017-09-08
K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory CO2016-07-08
K071781PF4 IGGGenetic Testing Institute2007-12-19
K071255ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040AHyphen Biomed2007-09-07
K053559PF4 ENHANCED SOLID PHASE ELISAGenetic Testing Institute2006-01-20
K040293HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAYAkers Laboratories, Inc.2004-05-28
K003767ASSERACHROM HPIA TEST KITDiagnostica Stago, Inc.2001-02-12
K983379GTI-PF4 ELISAGenetic Testing Institute1999-03-09
K890633ENZYGNOST PLATELET FACTOR 4 (PF4) KITBehring Diagnostics, Inc.1989-04-21
K862774ASSERACHROM PF4 KITAmerican Bioproducts Co.1986-09-04