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FDA 510(k)

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11

Número K: K220046 · 2022-12-13

RequerenteShenzhen Superbio Technology Co., Ltd.
Data da decisão2022-12-13
Código do produtoDJG
Comité consultivoTX
DecisãoSubstantially Equivalent

Resumo do dispositivo

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Superbio Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-13 under 510(k) number K220046. 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 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11?

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 is a medical device that received FDA 510(k) clearance on 2022-12-13. The listed applicant is Shenzhen Superbio Technology Co., Ltd.. The 510(k) number is K220046.

When did Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 receive FDA 510(k) clearance?

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 received FDA 510(k) clearance on 2022-12-13, under 510(k) number K220046.

Who is the listed applicant for Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11?

The FDA 510(k) record lists Shenzhen Superbio Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11?

The FDA product code for Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 is DJG.

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Dispositivos Relacionados (Código: DJG)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

Fonte oficial

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