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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 K092500
Device Name MODIFICATION TO PROFLU+ ASSAY
Applicant
PRODESSE, INC.
W229N1870 WESTWOOD DR.
waukesha,  WI  53186
Applicant Contact kristine schraufnagel
Correspondent
PRODESSE, INC.
W229N1870 WESTWOOD DR.
waukesha,  WI  53186
Correspondent Contact kristine schraufnagel
Regulation Number866.3980
Classification Product Code
OCC  
Date Received08/14/2009
Decision Date 08/20/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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