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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem S. R. 1.. It received FDA 510(k) clearance on 2020-04-06 under 510(k) 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. The listed applicant is Liofilchem S. R. 1.. The 510(k) number is K200308.

When did MTS Lefamulin 0.016- 256 µg/mL receive FDA 510(k) clearance?

MTS Lefamulin 0.016- 256 µg/mL received FDA 510(k) clearance on 2020-04-06, under 510(k) number K200308.

Who is the listed applicant for MTS Lefamulin 0.016- 256 µg/mL?

The FDA 510(k) record lists Liofilchem S. R. 1. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SAK260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher ScientificK250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher ScientificK252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 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.

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