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FDA 510(k)

ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

K-Number: K192738 · 2019-11-26

ApplicantBiomerieux S.A.
Decision Date2019-11-26
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) is a medical device manufactured by Biomerieux S.A.. It received FDA 510(k) clearance on 2019-11-26 under approval number K192738. 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 Delafloxacin (DFX) (0.002-32 µg/mL)?

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Biomerieux S.A.. The 510(k) number is K192738.

When was ETEST Delafloxacin (DFX) (0.002-32 µg/mL) approved by the FDA?

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) received FDA 510(k) clearance on 2019-11-26, under approval number K192738.

What company makes ETEST Delafloxacin (DFX) (0.002-32 µg/mL)?

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) is manufactured by Biomerieux S.A..

What is the FDA product code for ETEST Delafloxacin (DFX) (0.002-32 µg/mL)?

The FDA product code for ETEST Delafloxacin (DFX) (0.002-32 µg/mL) is JWY.

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Related Devices (Code: 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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