FDA 510(k)

MTS Gentamicin 0.016 - 256 µg/mL

K-Number: K190252 · 2019-03-22

Decision Date2019-03-22

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MTS Gentamicin 0.016 - 256 µg/mL is a medical device manufactured by Liofilchem s.r.l.. It received FDA 510(k) clearance on 2019-03-22 under approval number K190252. 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 MTS Gentamicin 0.016 - 256 µg/mL?

MTS Gentamicin 0.016 - 256 µg/mL is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Liofilchem s.r.l.. The 510(k) number is K190252.

When was MTS Gentamicin 0.016 - 256 µg/mL approved by the FDA?

MTS Gentamicin 0.016 - 256 µg/mL received FDA 510(k) clearance on 2019-03-22, under approval number K190252.

What company makes MTS Gentamicin 0.016 - 256 µg/mL?

MTS Gentamicin 0.016 - 256 µg/mL is manufactured by Liofilchem s.r.l..

What is the FDA product code for MTS Gentamicin 0.016 - 256 µg/mL?

The FDA product code for MTS Gentamicin 0.016 - 256 µg/mL is JWY.

Other Devices by Liofilchem s.r.l.

K162854Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml K161175Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL K153569Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml K153687Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL K173307Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL K172542Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.

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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.