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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K132129
Device Name PRODESSE PROFLU+ ASSAY
Original Applicant
GEN-PROBE PRODESSE, INC.
20925 crossroads circle
waukesha,  WI  53186
Original Contact emily ziegler
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received07/10/2013
Decision Date 08/09/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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