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FDA 510(k)

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

K-Number: K183031 · 2019-01-11

ApplicantBiomerieux S.A.
Decision Date2019-01-11
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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

When was ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) approved by the FDA?

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

What company makes ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)?

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) is manufactured by Biomerieux S.A..

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.

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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

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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