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FDA 510(k)

N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET

K-Number: K040241 · 2004-06-25

ApplicantGenzyme Corp.
Decision Date2004-06-25
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 2004-06-25 under 510(k) number K040241. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET?

N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 2004-06-25. The listed applicant is Genzyme Corp.. The 510(k) number is K040241.

When did N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET receive FDA 510(k) clearance?

N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET received FDA 510(k) clearance on 2004-06-25, under 510(k) number K040241.

Who is the listed applicant for N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET?

The FDA 510(k) record lists Genzyme Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET?

The FDA product code for N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET is DCK.

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Related Devices (Code: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

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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