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FDA 510(k)

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

N.º K: K142993 · 2016-03-10

SolicitanteOrion Diagnostica, OY
Fecha de decisión2016-03-10
Código de productoDCK
Comité asesorIM
DecisiónSubstantially Equivalent

Resumen del dispositivo

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, OY. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K142993. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument?

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Orion Diagnostica, OY. The 510(k) number is K142993.

When did QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument receive FDA 510(k) clearance?

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument received FDA 510(k) clearance on 2016-03-10, under 510(k) number K142993.

Who is the listed applicant for QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument?

The FDA 510(k) record lists Orion Diagnostica, OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument?

The FDA product code for QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument is DCK.

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Dispositivos relacionados (Código: DCK)

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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