FDA 510(k) Application Details - K955436

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K955436
Device Name	Radioassay, Vitamin B12
Applicant	BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	DENNIS GRIFFIN 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	10/02/1995
Decision Date	01/24/1996
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