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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 K073029
Device Name PROFLU+ ASSAY
Applicant
PRODESSE, INC.
w229 n1870 westwood dr.
waukesha,  WI  53186
Contact karen harrington
Regulation Number866.3980
Classification Product Code
OCC  
Date Received10/29/2007
Decision Date 01/04/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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