FDA 510(k) Application Details - K123274

Device Classification Name	More FDA Info for this Device
510(K) Number	K123274
Device Name	PROGASTRO SSCS ASSAY
Applicant	GEN-PROBE PRODESSE, INC. 20925 CROSSROADS CIRCLE WAUKESHA, WI 53186 US Other 510(k) Applications for this Company
Contact	KAREN HARRINGTON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2012
Decision Date	01/16/2013
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