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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mass Spectrometry, Microorganism Identification, Blood Culture
510(k) Number K240854
Device Name Accelerate Arc System
Applicant
Accelerate Diagnostics, Inc.
3950 S. Country Club Rd.
Tucson,  AZ  85714
Applicant Contact Jack Phillips
Correspondent
Precision For Medicine, Inc.
2 Bethesda Metro Center,
Suite 850
Bethesda,  MD  20814
Correspondent Contact Jo-Ann Gonzales
Classification Product Code
QNJ  
Date Received03/28/2024
Decision Date 09/26/2024
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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