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FDA 510(k)

ETEST Fosfomycin (FO) (0.032-512 µg/mL)

K-Number: K210757 · 2021-11-12

ApplicantBiomerieux S.A.
Decision Date2021-11-12
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST Fosfomycin (FO) (0.032-512 µg/mL) is a medical device manufactured by Biomerieux S.A.. It received FDA 510(k) clearance on 2021-11-12 under approval number K210757. 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 Fosfomycin (FO) (0.032-512 µg/mL)?

ETEST Fosfomycin (FO) (0.032-512 µg/mL) is a medical device that received FDA 510(k) clearance on 2021-11-12. It is manufactured by Biomerieux S.A.. The 510(k) number is K210757.

When was ETEST Fosfomycin (FO) (0.032-512 µg/mL) approved by the FDA?

ETEST Fosfomycin (FO) (0.032-512 µg/mL) received FDA 510(k) clearance on 2021-11-12, under approval number K210757.

What company makes ETEST Fosfomycin (FO) (0.032-512 µg/mL)?

ETEST Fosfomycin (FO) (0.032-512 µg/mL) is manufactured by Biomerieux S.A..

What is the FDA product code for ETEST Fosfomycin (FO) (0.032-512 µg/mL)?

The FDA product code for ETEST Fosfomycin (FO) (0.032-512 µg/mL) is JWY.

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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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