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510(k) K221688

ASTar BC G- Kit and ASTar Instrument by Q-Linea AB — Product Code SAN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 26, 2024
Date Received: June 10, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Device Class: Class II
Regulation Number: 866.1650
Review Panel: MI
Submission Type

Automated system that performs antimicrobial susceptibility testing using positive blood culture samples

Other clearances for product code SAN

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K230675 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (June 20, 2024)
K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (April 2, 2024)