FDA 510(k) Application Details - K122062

Device Classification Name	More FDA Info for this Device
510(K) Number	K122062
Device Name	APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
Applicant	GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121-4362 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	07/13/2012
Decision Date	01/09/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review