FDA 510(k) Application Details - K192064

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K192064
Device Name	Radioassay, Vitamin B12
Applicant	DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082-0285 US Other 510(k) Applications for this Company
Contact	John C. Walter 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	08/01/2019
Decision Date	10/02/2019
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