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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 K062948
Device Name SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
Applicant
CEPHEID
904 CARIBBEAN DRIVE
sunnyvale,  CA  94089 -1189
Applicant Contact russel k enns
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
sunnyvale,  CA  94089 -1189
Correspondent Contact russel k enns
Regulation Number866.3740
Classification Product Code
NJR  
Date Received09/28/2006
Decision Date 12/08/2006
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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