Class Class II

VITEK® 2 AST-Gram Negative Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (K223478)

K223478 2023-02-16 Traditional

Description

VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin by bioMerieux, Inc. — FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II

510(k) NumberK223478

Clearance Date2023-02-16

Clearance TypeTraditional

Product CodeLON

Regulation Number866.1645

FDA Database

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VITEK® 2 AST-Gram Negative Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (K223478)

Description

Regulatory Information

FDA Database

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