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 a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-09-15 under approval 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. It is manufactured by bioMerieux, Inc.. The 510(k) number is K172150.

When was Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) approved by the FDA?

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

What company makes Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)?

Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) is manufactured by bioMerieux, Inc..

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.

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Related Devices (Code: JWY)

K162854Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/mlLiofilchem s.r.l. K161175Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mLLiofilchem s.r.l. K153569Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/mlLiofilchem s.r.l. K153687Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mLLiofilchem s.r.l. K173307Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mLLiofilchem s.r.l. K173209Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mLThermo Fisher Scientific

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.