FDA 510(k)

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

K-Number: K183031 · 2019-01-11

Decision Date2019-01-11

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/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 2019-01-11 under 510(k) number K183031. 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 Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)?

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Biomerieux S.A.. The 510(k) number is K183031.

When did ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) receive FDA 510(k) clearance?

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) received FDA 510(k) clearance on 2019-01-11, under 510(k) number K183031.

Who is the listed applicant for ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/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 Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)?

The FDA product code for ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) is JWY.

Other records listing Biomerieux S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.