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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
FOIA Releasable 510(k) K121710
Device Name XPERT CT/NG
Applicant
CEPHEID
904 CARIBBEAN DRIVE
Sunnyvale,  CA  94089
Applicant Contact RUSSEL K ENNS
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
Sunnyvale,  CA  94089
Correspondent Contact RUSSEL K ENNS
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Codes
MKZ   OOI  
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
Recalls CDRH Recalls
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