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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
Contact kristine schraufnagel
Regulation Number866.3980
Classification Product Code
OCC  
Date Received08/14/2009
Decision Date 08/20/2009
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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