FDA 510(k)

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

K-Number: K250274 · 2025-04-30

Decision Date2025-04-30

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) is a medical device manufactured by Biomerieux S.A.. It received FDA 510(k) clearance on 2025-04-30 under approval number K250274. 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 Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)?

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) is a medical device that received FDA 510(k) clearance on 2025-04-30. It is manufactured by Biomerieux S.A.. The 510(k) number is K250274.

When was ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) approved by the FDA?

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) received FDA 510(k) clearance on 2025-04-30, under approval number K250274.

What company makes ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)?

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) is manufactured by Biomerieux S.A..

What is the FDA product code for ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)?

The FDA product code for ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) is JWY.

Other Devices by Biomerieux S.A.

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Related Devices (Code: JWY)

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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.