FDA 510(k) Application Details - K113731

Device Classification Name	Clinical Sample Concentrator   More FDA Info for this Device
510(K) Number	K113731
Device Name	Clinical Sample Concentrator
Applicant	CLINICAL MICRO SENSORS, INC. 5964 LA PLACE COURT CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	JOEL CENTENO Other 510(k) Applications for this Contact
Regulation Number	862.2310   More FDA Info for this Regulation Number
Classification Product Code	JJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2011
Decision Date	09/10/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review