FDA 510(k)

LZI Fentanyl Enzyme Immunoassay

Número K: K181159 · 2018-12-03

Data da decisão2018-12-03

Código do produtoDJG

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

LZI Fentanyl 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 2018-12-03 under 510(k) number K181159. 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 Fentanyl Enzyme Immunoassay?

LZI Fentanyl Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2018-12-03. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K181159.

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

LZI Fentanyl Enzyme Immunoassay received FDA 510(k) clearance on 2018-12-03, under 510(k) number K181159.

Who is the listed applicant for LZI Fentanyl 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 Fentanyl Enzyme Immunoassay?

The FDA product code for LZI Fentanyl Enzyme Immunoassay is DJG.

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Outros registros que listam Lin-Zhi International, Inc. como candidato(a)

K253082LZI Buprenorphine II Enzyme Immunoassay K251634LZI Fentanyl III Enzyme Immunoassay K202007LZI Oxycodone III Enzyme Immunoassay K201938LZI Fentanyl II Enzyme Immunoassay K201223LZI Tramadol Enzyme Immunoassay K192299LZI Cotinine II Enzyme Immunoassay

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Dispositivos Relacionados (Código: DJG)

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLC K251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

Fonte oficial

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