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FDA 510(k)

N HIGH SENSITIVITY CRP

K-Number: K033908 · 2004-01-22

ApplicantDade Behring, Inc.
Decision Date2004-01-22
Product CodeNQD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N HIGH SENSITIVITY CRP is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2004-01-22 under 510(k) number K033908. 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 N HIGH SENSITIVITY CRP?

N HIGH SENSITIVITY CRP is a medical device that received FDA 510(k) clearance on 2004-01-22. The listed applicant is Dade Behring, Inc.. The 510(k) number is K033908.

When did N HIGH SENSITIVITY CRP receive FDA 510(k) clearance?

N HIGH SENSITIVITY CRP received FDA 510(k) clearance on 2004-01-22, under 510(k) number K033908.

Who is the listed applicant for N HIGH SENSITIVITY CRP?

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

What is the FDA product code for N HIGH SENSITIVITY CRP?

The FDA product code for N HIGH SENSITIVITY CRP is NQD.

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Related Devices (Code: NQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260026Tina-quant Cardiac high sensitivity CRP IIIRoche DiagnosticsK233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc.K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbHK173833CRP VarioSENTINEL CH. SpAK081294ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORSSiemens Healthcare Diagnostics, Inc.K071002IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENTBeckman Coulter, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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