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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 K121710
Device Name XPERT CT/NG
Original Applicant
904 caribbean drive
sunnyvale,  CA  94089
Original Contact russel k enns
Regulation Number866.3390
Classification Product Code
Subsequent Product Codes
Date Received06/11/2012
Decision Date 12/27/2012
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