FDA 510(k)

Quidel Triage® TOX Drug Screen, 94600

N.º K: K200363 · 2020-03-11

Fecha de decisión2020-03-11

Código de productoDKZ

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

Quidel Triage® TOX Drug Screen, 94600 is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Cardiovascular, Inc.. It received FDA 510(k) clearance on 2020-03-11 under 510(k) number K200363. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Quidel Triage® TOX Drug Screen, 94600?

Quidel Triage® TOX Drug Screen, 94600 is a medical device that received FDA 510(k) clearance on 2020-03-11. The listed applicant is Quidel Cardiovascular, Inc.. The 510(k) number is K200363.

When did Quidel Triage® TOX Drug Screen, 94600 receive FDA 510(k) clearance?

Quidel Triage® TOX Drug Screen, 94600 received FDA 510(k) clearance on 2020-03-11, under 510(k) number K200363.

Who is the listed applicant for Quidel Triage® TOX Drug Screen, 94600?

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

What is the FDA product code for Quidel Triage® TOX Drug Screen, 94600?

The FDA product code for Quidel Triage® TOX Drug Screen, 94600 is DKZ.

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Otros registros que enlistan a Quidel Cardiovascular, Inc. como solicitante

K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro

Dispositivos relacionados (Código: DKZ)

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Fuente oficial

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