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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 K132159
Device Name PROADENO+ ASSAY
Applicant
GEN-PROBE PRODESSE, INC
20925 CROSSROADS CIRCLE
WAUKESHA,  WI  53186
Applicant Contact EMILY ZIEGLER
Correspondent
GEN-PROBE PRODESSE, INC
20925 CROSSROADS CIRCLE
WAUKESHA,  WI  53186
Correspondent Contact EMILY ZIEGLER
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received07/12/2013
Decision Date 08/14/2013
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
Predetermined Change
Control Plan Authorized		 No
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