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FDA 510(k)

AllSource Detector de Drogas FenTest; AllSource Detector de Drogas Fentanil Test

Número K: K234006 · 2024-03-21

RequerenteAllsource Screening Solutions
Data da decisão2024-03-21
Código do produtoNGL
Comité consultivoTX
DecisãoSubstantially Equivalent

Resumo do dispositivo

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test is the device name listed in this FDA 510(k) record. The listed applicant is Allsource Screening Solutions. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K234006. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test?

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Allsource Screening Solutions. The 510(k) number is K234006.

When did AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test receive FDA 510(k) clearance?

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test received FDA 510(k) clearance on 2024-03-21, under 510(k) number K234006.

Who is the listed applicant for AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test?

The FDA 510(k) record lists Allsource Screening Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test?

The FDA product code for AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test is NGL.

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Dispositivos Relacionados (Código: NGL)

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Fonte oficial

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