FDA 510(k) Application Details - K972295

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster   More FDA Info for this Device
510(K) Number	K972295
Device Name	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Applicant	QUEST INTL., INC. 1938 N.E. 148TH TERR. NORTH MIAMI, FL 33181 US Other 510(k) Applications for this Company
Contact	ROBERT A CORT 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	06/19/1997
Decision Date	11/05/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review