FDA 510(k) Application Details - K951848

Device Classification Name	Radioimmunoassay, C-Peptides Of Proinsulin   More FDA Info for this Device
510(K) Number	K951848
Device Name	Radioimmunoassay, C-Peptides Of Proinsulin
Applicant	TOSOH MEDICS, INC. 373 D VINTAGE PARK DR. FOSTER CITY, CA 94404 US Other 510(k) Applications for this Company
Contact	LORI ROBINSON Other 510(k) Applications for this Contact
Regulation Number	862.1135   More FDA Info for this Regulation Number
Classification Product Code	JKD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/1995
Decision Date	02/13/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review