FDA 510(k) Application Details - K153137

Device Classification Name	Platelet Factor 4 Radioimmunoassay   More FDA Info for this Device
510(K) Number	K153137
Device Name	Platelet Factor 4 Radioimmunoassay
Applicant	INSTRUMENTATION LABORATORY CO. 180 HARTWELL Road BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	Carol Marble Other 510(k) Applications for this Contact
Regulation Number	864.7695   More FDA Info for this Regulation Number
Classification Product Code	LCO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2015
Decision Date	07/08/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review