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FDA 510(k)

ETEST Telavancin (TLA) (0.002-32 ug/mL)

K-Number: K180936 · 2018-07-03

ApplicantBiomerieux S.A.
Decision Date2018-07-03
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST Telavancin (TLA) (0.002-32 ug/mL) is a medical device manufactured by Biomerieux S.A.. It received FDA 510(k) clearance on 2018-07-03 under approval number K180936. 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 Telavancin (TLA) (0.002-32 ug/mL)?

ETEST Telavancin (TLA) (0.002-32 ug/mL) is a medical device that received FDA 510(k) clearance on 2018-07-03. It is manufactured by Biomerieux S.A.. The 510(k) number is K180936.

When was ETEST Telavancin (TLA) (0.002-32 ug/mL) approved by the FDA?

ETEST Telavancin (TLA) (0.002-32 ug/mL) received FDA 510(k) clearance on 2018-07-03, under approval number K180936.

What company makes ETEST Telavancin (TLA) (0.002-32 ug/mL)?

ETEST Telavancin (TLA) (0.002-32 ug/mL) is manufactured by Biomerieux S.A..

What is the FDA product code for ETEST Telavancin (TLA) (0.002-32 ug/mL)?

The FDA product code for ETEST Telavancin (TLA) (0.002-32 ug/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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