FDA 510(k) Application Details - K964348

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K964348
Device Name	Radioassay, Vitamin B12
Applicant	TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D FOSTER CITY, CA 94404 US Other 510(k) Applications for this Company
Contact	LORI ROBINSON Other 510(k) Applications for this Contact
Regulation Number	862.1810   More FDA Info for this Regulation Number
Classification Product Code	CDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/1996
Decision Date	01/13/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review