FDA 510(k)

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

K-Number: K210757 · 2021-11-12

Decision Date2021-11-12

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ETEST Fosfomycin (FO) (0.032-512 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux S.A.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) 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. The listed applicant is Biomerieux S.A.. The 510(k) number is K210757.

When did ETEST Fosfomycin (FO) (0.032-512 µg/mL) receive FDA 510(k) clearance?

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

Who is the listed applicant for ETEST Fosfomycin (FO) (0.032-512 µg/mL)?

The FDA 510(k) record lists Biomerieux S.A. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Biomerieux S.A. as applicant

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Related Devices (Code: JWY)

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Official Source

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