FDA 510(k)

LZI Buprenorphine II Enzyme Immunoassay

Número K: K253082 · 2026-01-16

Data da decisão2026-01-16

Código do produtoDJG

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

LZI Buprenorphine II 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 2026-01-16 under 510(k) number K253082. 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 Buprenorphine II Enzyme Immunoassay?

LZI Buprenorphine II Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K253082.

When did LZI Buprenorphine II Enzyme Immunoassay receive FDA 510(k) clearance?

LZI Buprenorphine II Enzyme Immunoassay received FDA 510(k) clearance on 2026-01-16, under 510(k) number K253082.

Who is the listed applicant for LZI Buprenorphine II 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 Buprenorphine II Enzyme Immunoassay?

The FDA product code for LZI Buprenorphine II Enzyme Immunoassay is DJG.

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Fonte oficial

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