FDA 510(k) Application Details - K040293

Device Classification Name	Platelet Factor 4 Radioimmunoassay   More FDA Info for this Device
510(K) Number	K040293
Device Name	Platelet Factor 4 Radioimmunoassay
Applicant	AKERS LABORATORIES, INC. 201 GROVE RD. THOROFARE, NJ 08086 US Other 510(k) Applications for this Company
Contact	BARBARA A BAGBY 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	02/06/2004
Decision Date	05/28/2004
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