Class Class II

VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (K222430)

K222430 2023-03-09 Traditional

Description

VITEK 2 AST-Gram Negative Fosfomycin (=256 µg/mL), VITEK 2 AST-GN Fosfomycin (=256 µg/mL), VITEK 2 AST-GN Fosfomycin by Biomerieux Sa, Inc. — FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II

510(k) NumberK222430

Clearance Date2023-03-09

Clearance TypeTraditional

Product CodeLON

Regulation Number866.1645

FDA Database

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VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (K222430)

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