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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 K102952
Device Name PRODESSE PROADENO
Applicant
GEN-PROBE PRODESSE, INC
w229 n1870 westwood dr
waukesha,  WI  53186
Contact emily zielger
Regulation Number866.3980
Classification Product Code
OCC  
Date Received10/05/2010
Decision Date 12/03/2010
Decision substantially equivalent - CLIA submission (CS)
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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