FDA 510(k) Application Details - K972895

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Rotavirus   More FDA Info for this Device
510(K) Number	K972895
Device Name	Enzyme Linked Immunoabsorbent Assay, Rotavirus
Applicant	BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. ROCKLAND, MA 02370 US Other 510(k) Applications for this Company
Contact	TERRY MCGOVERN Other 510(k) Applications for this Contact
Regulation Number	866.3405   More FDA Info for this Regulation Number
Classification Product Code	LIQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/1997
Decision Date	10/03/1997
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