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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 K081030
Device Name MODIFICATION TO PROFLU+ ASSAY
Applicant
PRODESSE, INC.
W229 N1870 WESTWOOD DR.
WAUKESHA,  WI  53186
Applicant Contact KAREN HARRINGTON
Correspondent
PRODESSE, INC.
W229 N1870 WESTWOOD DR.
WAUKESHA,  WI  53186
Correspondent Contact KAREN HARRINGTON
Regulation Number866.3980
Classification Product Code
OCC  
Date Received04/11/2008
Decision Date 05/02/2008
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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