FDA 510(k) Application Details - K192586

Device Classification Name	Acid, Folic, Radioimmunoassay   More FDA Info for this Device
510(K) Number	K192586
Device Name	Acid, Folic, Radioimmunoassay
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	862.1295   More FDA Info for this Regulation Number
Classification Product Code	CGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2019
Decision Date	05/06/2020
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