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FDA 510(k)

Optilite High Sensitivity C-Reactive Protein Kit

K-Number: K180099 · 2018-10-12

ApplicantThe Binding Site Group , Ltd.
Decision Date2018-10-12
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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

When was Optilite High Sensitivity C-Reactive Protein Kit approved by the FDA?

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

What company makes Optilite High Sensitivity C-Reactive Protein Kit?

Optilite High Sensitivity C-Reactive Protein Kit is manufactured by The Binding Site Group , Ltd..

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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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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