FDA 510(k)

Optilite High Sensitivity C-Reactive Protein Kit

N.º K: K180099 · 2018-10-12

SolicitanteThe Binding Site Group , Ltd.

Fecha de decisión2018-10-12

Código de productoDCN

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Optilite High Sensitivity C-Reactive Protein Kit is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K180099. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Optilite High Sensitivity C-Reactive Protein Kit?

Optilite High Sensitivity C-Reactive Protein Kit is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K180099.

When did Optilite High Sensitivity C-Reactive Protein Kit receive FDA 510(k) clearance?

Optilite High Sensitivity C-Reactive Protein Kit received FDA 510(k) clearance on 2018-10-12, under 510(k) number K180099.

Who is the listed applicant for Optilite High Sensitivity C-Reactive Protein Kit?

The FDA 510(k) record lists The Binding Site Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optilite High Sensitivity C-Reactive Protein Kit?

The FDA product code for Optilite High Sensitivity C-Reactive Protein Kit is DCN.

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Fuente oficial

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