FDA 510(k)

Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)

K-Number: K172150 · 2017-09-15

Decision Date2017-09-15

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K172150. 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 Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)?

Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is bioMerieux, Inc.. The 510(k) number is K172150.

When did Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) receive FDA 510(k) clearance?

Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) received FDA 510(k) clearance on 2017-09-15, under 510(k) number K172150.

Who is the listed applicant for Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)?

The FDA 510(k) record lists bioMerieux, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)?

The FDA product code for Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) is JWY.

Other records listing bioMerieux, Inc. as applicant

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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.