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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 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 2018-10-12 under 510(k) 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. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K180099.

When did Optilite High Sensitivity C-Reactive Protein Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Optilite High Sensitivity C-Reactive Protein Kit?

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 High Sensitivity C-Reactive Protein Kit?

The FDA product code for Optilite High Sensitivity C-Reactive Protein Kit is DCN.

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Other records listing The Binding Site Group , Ltd. as applicant

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Related Devices (Code: DCN)

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K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)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, LLCK161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group

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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