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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
510(k) Number K253316
Device Name PhAST instrument and PhAST Blood Culture Gram-negative Panel
Applicant
Phast Corp.
38 Wareham St.
Floor 2
Boston,  MA  02118
Applicant Contact Roman Stocker
Correspondent
MDC Associates
48 Dunham Ridge Rd.
Suite 4000
Beverly,  MA  01915
Correspondent Contact Katie Hahnemann
Classification Product Code
SAN  
Subsequent Product Code
LON  
Date Received09/30/2025
Decision Date 06/26/2026
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		 Yes
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