FDA 510(k) Application Details - K061301

Device Classification Name	System, Transport, Aerobic   More FDA Info for this Device
510(K) Number	K061301
Device Name	System, Transport, Aerobic
Applicant	COPAN DIAGNOSTICS, INC. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA SINCLAIR Other 510(k) Applications for this Contact
Regulation Number	866.2900   More FDA Info for this Regulation Number
Classification Product Code	JTW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2006
Decision Date	06/23/2006
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