FDA 510(k)

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

K-Number: K180936 · 2018-07-03

Decision Date2018-07-03

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ETEST Telavancin (TLA) (0.002-32 ug/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 2018-07-03 under 510(k) 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. The listed applicant is Biomerieux S.A.. The 510(k) number is K180936.

When did ETEST Telavancin (TLA) (0.002-32 ug/mL) receive FDA 510(k) clearance?

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

Who is the listed applicant for ETEST Telavancin (TLA) (0.002-32 ug/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 Telavancin (TLA) (0.002-32 ug/mL)?

The FDA product code for ETEST Telavancin (TLA) (0.002-32 ug/mL) is JWY.

Other records listing Biomerieux S.A. as applicant

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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.