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FDA 510(k)

CardioPhase® hsCRP

K-Number: K212559 · 2022-12-16

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2022-12-16
Product CodeNQD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CardioPhase® hsCRP is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K212559. 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 CardioPhase® hsCRP?

CardioPhase® hsCRP is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K212559.

When did CardioPhase® hsCRP receive FDA 510(k) clearance?

CardioPhase® hsCRP received FDA 510(k) clearance on 2022-12-16, under 510(k) number K212559.

Who is the listed applicant for CardioPhase® hsCRP?

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

What is the FDA product code for CardioPhase® hsCRP?

The FDA product code for CardioPhase® hsCRP 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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