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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positive Blood Culture Identification And Ast Kit
510(k) Number K192665
Device Name Accelerate Pheno System, Accelerate PhenoTest BC Kit
Applicant
Accelerate Diagnostics, Inc.
3950 S. Country Club Road #470
Tucson,  AZ  85714
Applicant Contact Carrene Plummer
Correspondent
Accelerate Diagnostics, Inc.
3950 S. Country Club Road #470
Tucson,  AZ  85714
Correspondent Contact Carrene Plummer
Classification Product Code
PRH  
Subsequent Product Codes
LON   NSU   PAM   PEN   PEO  
Date Received09/25/2019
Decision Date 09/15/2020
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
Recalls CDRH Recalls
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