FDA 510(k) Application Details - K003767

Device Classification Name	Platelet Factor 4 Radioimmunoassay   More FDA Info for this Device
510(K) Number	K003767
Device Name	Platelet Factor 4 Radioimmunoassay
Applicant	DIAGNOSTICA STAGO, INC. FIVE CENTURY DR. PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	ANDREW LOC B LE 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	12/06/2000
Decision Date	02/12/2001
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