FDA 510(k) Application Details - K032306

Device Classification Name	System, Blood Culturing   More FDA Info for this Device
510(K) Number	K032306
Device Name	System, Blood Culturing
Applicant	TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 CLEVELAND, OH 44131 US Other 510(k) Applications for this Company
Contact	NADINE M SULLIVAN 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	07/25/2003
Decision Date	08/22/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review