FDA 510(k) Application Details - K972756

Device Classification Name	System, Blood Culturing   More FDA Info for this Device
510(K) Number	K972756
Device Name	System, Blood Culturing
Applicant	ACCUMED INTL., INC. 29299 CLEMENS RD. SUITE 1K WESTLAKE, OH 44145 US Other 510(k) Applications for this Company
Contact	CYNTHIA C KNAPP Other 510(k) Applications for this Contact
Regulation Number	866.2560   More FDA Info for this Regulation Number
Classification Product Code	MDB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/1997
Decision Date	08/01/1997
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