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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 the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group. It received FDA 510(k) clearance on 2017-04-05 under 510(k) 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. The listed applicant is The Binding Site Group. The 510(k) number is K161982.

When did C-Reactive Protein Kit for use on SPAPLUS receive FDA 510(k) clearance?

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

Who is the listed applicant for C-Reactive Protein Kit for use on SPAPLUS?

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

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.

Other records listing The Binding Site Group as applicant

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Related Devices (Code: DCN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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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