FDA 510(k) Application Details - K150375

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster   More FDA Info for this Device
510(K) Number	K150375
Device Name	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Applicant	DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 US Other 510(k) Applications for this Company
Contact	John Walter Other 510(k) Applications for this Contact
Regulation Number	866.3900   More FDA Info for this Regulation Number
Classification Product Code	LFY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2015
Decision Date	03/11/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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