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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nucleic acid amplification assay system, group b streptococcus, direct specimen test
510(k) Number K121539
Models 900-0453, -0454, -0455, -0456, -0457, 900-0495, 0496,0497, 0498, 0499, 0500, 0501, 0502, 0503, GX-I-900-0423; GX-IV 900-0425, -0424, -0433, -0400, GX-XVI: 900-0429, -0427, -0426, GXGBS-LB-10
Device Name XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
Original Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089 1189
Original Contact kerry j flom
Regulation Number866.3740
Classification Product Code
NJR  
Subsequent Product Code
OOI  
Date Received05/24/2012
Decision Date 11/02/2012
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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