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510(k) K212849

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) by Biomérieux, Inc. — Product Code LON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2022
Date Received
September 7, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class
Class II
Regulation Number
866.1645
Review Panel
MI
Submission Type

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