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FDA 510(k)

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)

K-Number: K233242 · 2024-01-18

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2024-01-18
Product CodeNQD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-01-18 under approval number K233242. 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 Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)?

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K233242.

When was Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) approved by the FDA?

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) received FDA 510(k) clearance on 2024-01-18, under approval number K233242.

What company makes Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)?

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)?

The FDA product code for Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) 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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