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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, Antimicrobial Resistance Marker, Direct Specimen
510(k) Number K160901
Device Name Xpert Carba-R
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Applicant Contact SCOTT A. CAMPBELL
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Correspondent Contact JIM KELLY
Regulation Number866.1640
Classification Product Code
POC  
Subsequent Product Code
OOI  
Date Received04/01/2016
Decision Date 06/29/2016
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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