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FDA 510(k)

C-Reactive Protein Kit for use on SPAPLUS

K-Number: K161982 · 2017-04-05

ApplicantThe Binding Site Group
Decision Date2017-04-05
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

C-Reactive Protein Kit for use on SPAPLUS is a medical device manufactured by The Binding Site Group. It received FDA 510(k) clearance on 2017-04-05 under approval number K161982. 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 C-Reactive Protein Kit for use on SPAPLUS?

C-Reactive Protein Kit for use on SPAPLUS is a medical device that received FDA 510(k) clearance on 2017-04-05. It is manufactured by The Binding Site Group. The 510(k) number is K161982.

When was C-Reactive Protein Kit for use on SPAPLUS approved by the FDA?

C-Reactive Protein Kit for use on SPAPLUS received FDA 510(k) clearance on 2017-04-05, under approval number K161982.

What company makes C-Reactive Protein Kit for use on SPAPLUS?

C-Reactive Protein Kit for use on SPAPLUS is manufactured by The Binding Site Group.

What is the FDA product code for C-Reactive Protein Kit for use on SPAPLUS?

The FDA product code for C-Reactive Protein Kit for use on SPAPLUS is DCN.

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Official Source

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

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