FDA 510(k) Application Details - K960947

Device Classification Name	Test, Sickle Cell   More FDA Info for this Device
510(K) Number	K960947
Device Name	Test, Sickle Cell
Applicant	SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL SAN ANTONIO, TX 78240 US Other 510(k) Applications for this Company
Contact	HARBI SHADFAN Other 510(k) Applications for this Contact
Regulation Number	864.7825   More FDA Info for this Regulation Number
Classification Product Code	GHM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/1996
Decision Date	07/01/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review