FDA 510(k) Application Details - K122397

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Rubella   More FDA Info for this Device
510(K) Number	K122397
Device Name	Enzyme Linked Immunoabsorbent Assay, Rubella
Applicant	DIASORIN, INC. 1951 NORTHWESTERN AVE. STILLWATER, MN 55082-0285 US Other 510(k) Applications for this Company
Contact	CAROL A DEPOUW Other 510(k) Applications for this Contact
Regulation Number	866.3510   More FDA Info for this Regulation Number
Classification Product Code	LFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2012
Decision Date	09/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review