FDA 510(k)

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

N.º K: K172868 · 2018-02-28

SolicitanteThe Binding Site Group , Ltd.

Fecha de decisión2018-02-28

Código de productoDCN

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls 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 2018-02-28 under 510(k) number K172868. 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 C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls?

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K172868.

When did Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls receive FDA 510(k) clearance?

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls received FDA 510(k) clearance on 2018-02-28, under 510(k) number K172868.

Who is the listed applicant for Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls?

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 C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls?

The FDA product code for Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls is DCN.

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Otros registros que enlistan a The Binding Site Group , Ltd. como solicitante

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Dispositivos relacionados (Código: DCN)

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Fuente oficial

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