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FDA 510(k)

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

K-Number: K172868 · 2018-02-28

ApplicantThe Binding Site Group , Ltd.
Decision Date2018-02-28
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls is a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2018-02-28 under approval number K172868. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K172868.

When was Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls approved by the FDA?

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 approval number K172868.

What company makes 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 manufactured by The Binding Site Group , Ltd..

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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Other Devices by The Binding Site Group , Ltd.

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Related Devices (Code: DCN)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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