FDA 510(k) Application Details - K121314

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K121314
Device Name	Radioassay, Vitamin B12
Applicant	ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT. 09V6 AP5 NORTH ABBOTT PARK, IL 60064 US Other 510(k) Applications for this Company
Contact	DARLA A ABANO 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	05/02/2012
Decision Date	05/17/2012
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