FDA 510(k) Application Details - K160757

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K160757
Device Name	Radioassay, Vitamin B12
Applicant	AXIS-SHIELD DIAGNOSTICS LIMITED THE TECHNOLOGY PARK LUNA PLACE DUNDEE DD2 1XA GB Other 510(k) Applications for this Company
Contact	CLAIRE I. DORA 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	03/18/2016
Decision Date	07/26/2016
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