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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

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), Device, Applicant table
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