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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, Carbapenem Non-Susceptible Gram Negative Organism, Colony
510(k) Number K152614
Device Name Xpert Carba-R
Applicant
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089 -1189
Applicant Contact SCOTT A. CAMPBELL
Correspondent
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089 -1189
Correspondent Contact JIM KELLY
Regulation Number866.1640
Classification Product Code
PMY  
Subsequent Product Code
OOI  
Date Received09/14/2015
Decision Date 03/07/2016
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
Predetermined Change
Control Plan Authorized		 No
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