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FDA 510(k)

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

K-Number: K192050 · 2019-09-27

ApplicantBiomerieux S.A.
Decision Date2019-09-27
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) is a medical device manufactured by Biomerieux S.A.. It received FDA 510(k) clearance on 2019-09-27 under approval number K192050. 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 Eravacycline (ERV) (0.002 – 32 µg/mL)?

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Biomerieux S.A.. The 510(k) number is K192050.

When was ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) approved by the FDA?

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) received FDA 510(k) clearance on 2019-09-27, under approval number K192050.

What company makes ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)?

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) is manufactured by Biomerieux S.A..

What is the FDA product code for ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)?

The FDA product code for ETEST Eravacycline (ERV) (0.002 – 32 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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