FDA 510(k) Application Details - DEN110012

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN110012
Device Name	APTIMA TRICHOMONAS VAGINALIS ASSAY
Applicant	GEN-PROBE INCORPORATED 10210 Genetic Center Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	MARIA CARMELITA S BALUYOT Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2011
Decision Date	04/19/2011
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review