FDA 510(k)

OralTox Oral fluid Drug Test

Número K: K181305 · 2018-09-20

Data da decisão2018-09-20

Código do produtoDJC

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

OralTox Oral fluid Drug Test is the device name listed in this FDA 510(k) record. The listed applicant is Premier Biotech, Inc.. It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K181305. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OralTox Oral fluid Drug Test?

OralTox Oral fluid Drug Test is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is Premier Biotech, Inc.. The 510(k) number is K181305.

When did OralTox Oral fluid Drug Test receive FDA 510(k) clearance?

OralTox Oral fluid Drug Test received FDA 510(k) clearance on 2018-09-20, under 510(k) number K181305.

Who is the listed applicant for OralTox Oral fluid Drug Test?

The FDA 510(k) record lists Premier Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OralTox Oral fluid Drug Test?

The FDA product code for OralTox Oral fluid Drug Test is DJC.

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Outros registros que listam Premier Biotech, Inc. como candidato(a)

K171403OralTox Oral Fluid Drug Test

Dispositivos Relacionados (Código: DJC)

Fonte oficial

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