FDA 510(k)

LZI Oxycodone III Enzyme Immunoassay

Número K: K202007 · 2020-09-17

Data da decisão2020-09-17

Código do produtoDJG

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

LZI Oxycodone III Enzyme Immunoassay 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 2020-09-17 under 510(k) number K202007. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LZI Oxycodone III Enzyme Immunoassay?

LZI Oxycodone III Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K202007.

When did LZI Oxycodone III Enzyme Immunoassay receive FDA 510(k) clearance?

LZI Oxycodone III Enzyme Immunoassay received FDA 510(k) clearance on 2020-09-17, under 510(k) number K202007.

Who is the listed applicant for LZI Oxycodone III Enzyme Immunoassay?

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 Oxycodone III Enzyme Immunoassay?

The FDA product code for LZI Oxycodone III Enzyme Immunoassay is DJG.

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Dispositivos Relacionados (Código: DJG)

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Fonte oficial

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