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LCO — Platelet Factor 4 Radioimmunoassay Class II

FDA Device Classification

Classification Details

Product Code
LCO
Device Class
Class II
Regulation Number
864.7695
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K170854instrumentation laboratoryHemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsSeptember 8, 2017
K153137instrumentation laboratoryHemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsJuly 8, 2016
K071781genetic testing institutePF4 IGGDecember 19, 2007
K071255hyphen biomedZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040ASeptember 7, 2007
K053559genetic testing institutePF4 ENHANCED SOLID PHASE ELISAJanuary 20, 2006
K040293akers laboratoriesHEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAYMay 28, 2004
K003767diagnostica stagoASSERACHROM HPIA TEST KITFebruary 12, 2001
K983379genetic testing instituteGTI-PF4 ELISAMarch 9, 1999
K890633behring diagnosticsENZYGNOST PLATELET FACTOR 4 (PF4) KITApril 21, 1989
K862774american bioproductsASSERACHROM PF4 KITSeptember 4, 1986