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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 K173263
Device Name Xpert Carba-R
Applicant
Cepheid
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Yi-Ping Lin
Correspondent
Cepheid
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Jim Kelly
Regulation Number866.1640
Classification Product Code
POC  
Subsequent Product Codes
OOI   PMY  
Date Received10/11/2017
Decision Date 01/09/2018
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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