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FDA 510(k)

ETEST Plazomicin (PLZ) (0.016-256 µg/mL)

K-Number: K200512 · 2020-05-07

ApplicantBiomérieux SA
Decision Date2020-05-07
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST Plazomicin (PLZ) (0.016-256 µg/mL) is a medical device manufactured by Biomérieux SA. It received FDA 510(k) clearance on 2020-05-07 under approval number K200512. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETEST Plazomicin (PLZ) (0.016-256 µg/mL)?

ETEST Plazomicin (PLZ) (0.016-256 µg/mL) is a medical device that received FDA 510(k) clearance on 2020-05-07. It is manufactured by Biomérieux SA. The 510(k) number is K200512.

When was ETEST Plazomicin (PLZ) (0.016-256 µg/mL) approved by the FDA?

ETEST Plazomicin (PLZ) (0.016-256 µg/mL) received FDA 510(k) clearance on 2020-05-07, under approval number K200512.

What company makes ETEST Plazomicin (PLZ) (0.016-256 µg/mL)?

ETEST Plazomicin (PLZ) (0.016-256 µg/mL) is manufactured by Biomérieux SA.

What is the FDA product code for ETEST Plazomicin (PLZ) (0.016-256 µg/mL)?

The FDA product code for ETEST Plazomicin (PLZ) (0.016-256 µg/mL) is JWY.

Other Devices by Biomérieux SA

K210793VIDAS NEPHROCHECK

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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