FDA 510(k) Application Details - K971335

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus   More FDA Info for this Device
510(K) Number	K971335
Device Name	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant	INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	BRYS C MYERS Other 510(k) Applications for this Contact
Regulation Number	866.3175   More FDA Info for this Regulation Number
Classification Product Code	LFZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/1997
Decision Date	12/01/1997
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