FDA 510(k)

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL

Número K: K180886 · 2018-05-18

Data da decisão2018-05-18

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 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 2018-05-18 under 510(k) number K180886. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL?

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K180886.

When did Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL receive FDA 510(k) clearance?

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180886.

Who is the listed applicant for Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 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), Delafloxacin 0.002 - 32 ug/mL?

The FDA product code for Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL is JWY.

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Fonte oficial

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