FDA 510(k) Application Details - K972449

Device Classification Name	Culture Media, Anaerobic Transport   More FDA Info for this Device
510(K) Number	K972449
Device Name	Culture Media, Anaerobic Transport
Applicant	COPAN ITALIA SPA 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA A SINCLAIR Other 510(k) Applications for this Contact
Regulation Number	866.2390   More FDA Info for this Regulation Number
Classification Product Code	JSL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/1997
Decision Date	08/20/1997
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