FDA 510(k)

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators

Número K: K170416 · 2017-06-26

Data da decisão2017-06-26

Código do produtoDJR

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2017-06-26 under 510(k) number K170416. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators?

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is a medical device that received FDA 510(k) clearance on 2017-06-26. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K170416.

When did LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators receive FDA 510(k) clearance?

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators received FDA 510(k) clearance on 2017-06-26, under 510(k) number K170416.

Who is the listed applicant for LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators?

The FDA product code for LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is DJR.

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Dispositivos Relacionados (Código: DJR)

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Fonte oficial

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