FDA 510(k) Application Details - K973325

Device Classification Name	System, Blood Culturing   More FDA Info for this Device
510(K) Number	K973325
Device Name	System, Blood Culturing
Applicant	ORGANON TEKNIKA CORP. 100 AKZO AVE. DURHAM, NC 27712 US Other 510(k) Applications for this Company
Contact	REBECCA A RIVAS 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	09/04/1997
Decision Date	12/02/1997
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