FDA 510(k) Application Details - K972676

Device Classification Name	Kit, Screening, Urine   More FDA Info for this Device
510(K) Number	K972676
Device Name	Kit, Screening, Urine
Applicant	COMBACT DIAGNOSTIC SYSTEMS LTD. 16809 BRIARDALE RD. ROCKVILLE, MD 20855 US Other 510(k) Applications for this Company
Contact	THOMAS M TSAKERIS Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	JXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/1997
Decision Date	02/23/1998
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