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FDA 510(k)

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

N.º K: K161714 · 2016-10-14

SolicitanteImmunalysis Corporation
Fecha de decisión2016-10-14
Código de productoDIS
Comité asesorTX
DecisiónSubstantially Equivalent

Resumen del dispositivo

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161714. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Immunalysis Corporation. The 510(k) number is K161714.

When did Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators receive FDA 510(k) clearance?

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161714.

Who is the listed applicant for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

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

What is the FDA product code for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

The FDA product code for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is DIS.

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Otros registros que enlistan a Immunalysis Corporation como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

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

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