FDA 510(k)

Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml

K-Number: K162854 · 2016-12-19

Decision Date2016-12-19

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/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 2016-12-19 under 510(k) number K162854. 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 Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml?

Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K162854.

When did Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml receive FDA 510(k) clearance?

Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml received FDA 510(k) clearance on 2016-12-19, under 510(k) number K162854.

Who is the listed applicant for Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/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 Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml?

The FDA product code for Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/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.