FDA 510(k)

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

K-Number: K191809 · 2019-08-23

Decision Date2019-08-23

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem s.r.l.. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K191809. 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 Imipenem-relebactam 0.002/4-32/4 µg/mL?

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K191809.

When did MTS Imipenem-relebactam 0.002/4-32/4 µg/mL receive FDA 510(k) clearance?

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL received FDA 510(k) clearance on 2019-08-23, under 510(k) number K191809.

Who is the listed applicant for MTS Imipenem-relebactam 0.002/4-32/4 µg/mL?

The FDA 510(k) record lists Liofilchem s.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTS Imipenem-relebactam 0.002/4-32/4 µg/mL?

The FDA product code for MTS Imipenem-relebactam 0.002/4-32/4 µg/mL is JWY.

Other records listing Liofilchem s.r.l. as applicant

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.

K260696MTS Gepotidacin 0.016-256 µg/mL K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)K243202MTS Ceftobiprole 0.002-32 µg/mL K230479ComASP Cefiderocol 0.008-128 K211672MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

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Related Devices (Code: JWY)

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA K260696MTS 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 Scientific K250575The 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 Scientific K252014The 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.