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FDA 510(k)

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

Número K: K142993 · 2016-03-10

RequerenteOrion Diagnostica, OY
Data da decisão2016-03-10
Código do produtoDCK
Comité consultivoIM
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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