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FDA 510(k)

Tina-quant Cardiac high sensitivity CRP III

K-Number: K260026 · 2026-04-02

ApplicantRoche Diagnostics
Decision Date2026-04-02
Product CodeNQD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Tina-quant Cardiac high sensitivity CRP III is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2026-04-02 under approval number K260026. The device is classified under product code NQD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tina-quant Cardiac high sensitivity CRP III?

Tina-quant Cardiac high sensitivity CRP III is a medical device that received FDA 510(k) clearance on 2026-04-02. It is manufactured by Roche Diagnostics. The 510(k) number is K260026.

When was Tina-quant Cardiac high sensitivity CRP III approved by the FDA?

Tina-quant Cardiac high sensitivity CRP III received FDA 510(k) clearance on 2026-04-02, under approval number K260026.

What company makes Tina-quant Cardiac high sensitivity CRP III?

Tina-quant Cardiac high sensitivity CRP III is manufactured by Roche Diagnostics.

What is the FDA product code for Tina-quant Cardiac high sensitivity CRP III?

The FDA product code for Tina-quant Cardiac high sensitivity CRP III is NQD.

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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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