MTS Lefamulin 0.016- 256 µg/mL
K-Number: K200308 · 2020-04-06
ApplicantLiofilchem S. R. 1.
Decision Date2020-04-06
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
MTS Lefamulin 0.016- 256 µg/mL is a medical device manufactured by Liofilchem S. R. 1.. It received FDA 510(k) clearance on 2020-04-06 under approval number K200308. 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 Lefamulin 0.016- 256 µg/mL?
MTS Lefamulin 0.016- 256 µg/mL is a medical device that received FDA 510(k) clearance on 2020-04-06. It is manufactured by Liofilchem S. R. 1.. The 510(k) number is K200308.
When was MTS Lefamulin 0.016- 256 µg/mL approved by the FDA?
MTS Lefamulin 0.016- 256 µg/mL received FDA 510(k) clearance on 2020-04-06, under approval number K200308.
What company makes MTS Lefamulin 0.016- 256 µg/mL?
MTS Lefamulin 0.016- 256 µg/mL is manufactured by Liofilchem S. R. 1..
What is the FDA product code for MTS Lefamulin 0.016- 256 µg/mL?
The FDA product code for MTS Lefamulin 0.016- 256 µg/mL is JWY.
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.