FDA 510(k)

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

K-Number: K102535 · 2011-05-16

Decision Date2011-05-16

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 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 2011-05-16 under 510(k) number K102535. 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 IN 0.002-32 UG/ML AND 0.016-256 UG/ML?

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML is a medical device that received FDA 510(k) clearance on 2011-05-16. The listed applicant is Biomerieux S.A.. The 510(k) number is K102535.

When did ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML receive FDA 510(k) clearance?

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML received FDA 510(k) clearance on 2011-05-16, under 510(k) number K102535.

Who is the listed applicant for ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 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 IN 0.002-32 UG/ML AND 0.016-256 UG/ML?

The FDA product code for ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML is JWY.

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Other records listing Biomerieux S.A. as applicant

K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)K190154ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

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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.