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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
Device Name XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Applicant Contact KERRY J FLOM
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Correspondent 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 (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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