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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastrointestinal pathogen panel multiplex nucleic acid-based assay system
510(k) Number K123274
Device Name PROGASTRO SSCS ASSAY
Applicant
GEN-PROBE PRODESSE, INC.
20925 CROSSROADS CIRCLE
WAUKESHA,  WI  53186
Applicant Contact KAREN HARRINGTON
Correspondent
GEN-PROBE PRODESSE, INC.
20925 CROSSROADS CIRCLE
WAUKESHA,  WI  53186
Correspondent Contact KAREN HARRINGTON
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Codes
OOI   PCI  
Date Received10/19/2012
Decision Date 01/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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