FDA 510(k) Applications for Medical Device Product Code: LCO (Platelet Factor 4 Radioimmunoassay)

FDA 510(k) Applications for Medical Device Product Code "LCO"
(Platelet Factor 4 Radioimmunoassay)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K040293	AKERS LABORATORIES, INC.	HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY	05/28/2004
K003767	DIAGNOSTICA STAGO, INC.	ASSERACHROM HPIA TEST KIT	02/12/2001
K983379	GENETIC TESTING INSTITUTE	GTI-PF4 ELISA	03/09/1999
K053559	GENETIC TESTING INSTITUTE	PF4 ENHANCED SOLID PHASE ELISA	01/20/2006
K071781	GENETIC TESTING INSTITUTE	PF4 IGG	12/19/2007
K071255	HYPHEN BIOMED	ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A	09/07/2007
K201570	Immucor GTI Diagnostics, Inc.	PF4 Enhanced assay	09/11/2020
K201311	Immucor GTI Diagnostics, Inc.	PF4 IgG assay	06/18/2020
K243374	Instrumentation Laboratory (IL) Co.	HemosIL CL HIT-IgG(PF4-H)	01/28/2025
K170854	Instrumentation Laboratory Co.	HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls	09/08/2017
K153137	INSTRUMENTATION LABORATORY CO.	HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls	07/08/2016