FDA 510(k) Application Details - K965186

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K965186
Device Name	Radioassay, Vitamin B12
Applicant	ABBOTT LABORATORIES DEPT 49C, BLDG. AP31 200 ABBOTT RD. ABBOTT PARK, IL 60064-3537 US Other 510(k) Applications for this Company
Contact	LAURA L GRANITZ 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	12/24/1996
Decision Date	03/24/1997
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