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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 processor for inoculum preparation used for antimicrobial susceptibility testing
510(k) Number K231536
Device Name eQUANT System
Applicant
Avails Medical, Inc.
1455 Adams Dr. Ste 1288
Menlo Park,  CA  94025
Applicant Contact Meike Herget
Correspondent
MDC Associates
180 Cabot Street
Beverly,  MA  01915
Correspondent Contact Katie Hahnemann
Regulation Number866.1650
Classification Product Code
QZX  
Subsequent Product Code
JTN  
Date Received05/30/2023
Decision Date 02/08/2024
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
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