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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name parainfluenza multiplex nucleic acid assay
510(k) Number K091053
Device Name PROPARAFLU+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
OOU  
Date Received04/13/2009
Decision Date 11/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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