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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
Models 900-0453,-0454,-0455,-0456,-0457, CT/NGURINE-50; CT/NGSWAB-50, GX-I 900-0423; GX-IV 900-0425, -0424, -0433, -0400, GX-XVI: 900-0429,-0427,-0726, GXCT/NG-10
Device Name XPERT CT/NG
Original Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089
Original 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 - 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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