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FDA 510(k)

ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)

K-Number: K250856 · 2025-06-12

ApplicantBiomérieux
Decision Date2025-06-12
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) is a medical device manufactured by Biomérieux. It received FDA 510(k) clearance on 2025-06-12 under approval number K250856. 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 Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)?

ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by Biomérieux. The 510(k) number is K250856.

When was ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) approved by the FDA?

ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) received FDA 510(k) clearance on 2025-06-12, under approval number K250856.

What company makes ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)?

ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) is manufactured by Biomérieux.

What is the FDA product code for ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)?

The FDA product code for ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) is JWY.

Other Devices by Biomérieux

K232395ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD

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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