FDA 510(k) Application Details - K070062

Device Classification Name	Device, Specimen Collection   More FDA Info for this Device
510(K) Number	K070062
Device Name	Device, Specimen Collection
Applicant	DIESSE DIAGNOSTICA SENESE S.P.A 1690 W 38 PLACE UNIT B1 HIALEAH, FL 33012 US Other 510(k) Applications for this Company
Contact	RAUL ALVAREZ Other 510(k) Applications for this Contact
Regulation Number	866.2900   More FDA Info for this Regulation Number
Classification Product Code	LIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2007
Decision Date	07/30/2007
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	Y
Expedited Review