FDA 510(k)

OralTox Oral fluid Drug Test

N.º K: K181305 · 2018-09-20

Fecha de decisión2018-09-20

Código de productoDJC

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Premier Biotech, Inc. como solicitante

K171403OralTox Oral Fluid Drug Test

Dispositivos relacionados (Código: DJC)

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.