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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 the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-01-18 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K233242.

When did Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) receive FDA 510(k) clearance?

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

Who is the listed applicant for Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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