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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
510(k) Number K162444
Device Name Xpert MRSA NxG
Applicant
CEPHEID
904 CARIBBEAN DRIVE
sunnyvale,  CA  94089
Applicant Contact scott a. campbell
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
sunnyvale,  CA  94089
Correspondent Contact jim kelly
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Code
OOI  
Date Received08/31/2016
Decision Date 11/23/2016
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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