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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-reagents, neisseria
510(k) Number K063664
Device Name GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091
Original Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego,  CA  92121 -4362
Original Contact e. joseph mcmullen
Regulation Number866.3390
Classification Product Code
LSL  
Date Received12/08/2006
Decision Date 01/25/2007
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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