FDA 510(k) Application Details - K161522

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K161522
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	DiaSorin Inc. 1951 Northwestern Ave. P.O. Box 285 Stillwater, MN 55082-0285 US Other 510(k) Applications for this Company
Contact	John Walter Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2016
Decision Date	06/30/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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