FDA 510(k)

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

K-Number: K191953 · 2019-08-22

Decision Date2019-08-22

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) is a medical device manufactured by Biomerieux S.A.. It received FDA 510(k) clearance on 2019-08-22 under approval number K191953. 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 (IPR) (0.002/4-32/4 ug/mL)?

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) is a medical device that received FDA 510(k) clearance on 2019-08-22. It is manufactured by Biomerieux S.A.. The 510(k) number is K191953.

When was ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) approved by the FDA?

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) received FDA 510(k) clearance on 2019-08-22, under approval number K191953.

What company makes ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)?

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) is manufactured by Biomerieux S.A..

What is the FDA product code for ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)?

The FDA product code for ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) is JWY.

Other Devices by Biomerieux S.A.

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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.