FDA 510(k) Application Details - K121946

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K121946
Device Name	Radioassay, Vitamin B12
Applicant	AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK, LUNA PLACE DUNDEE, SCOTLAND DD2 1XA GB Other 510(k) Applications for this Company
Contact	SIMON JOHN RICHARDS 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	07/03/2012
Decision Date	03/22/2013
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