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FDA 510(k)

RCRP FLEX REAGENT CARTRIDGE

K-Number: K003419 · 2001-02-14

ApplicantDade Behring, Inc.
Decision Date2001-02-14
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RCRP FLEX REAGENT CARTRIDGE 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 2001-02-14 under 510(k) number K003419. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RCRP FLEX REAGENT CARTRIDGE?

RCRP FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Dade Behring, Inc.. The 510(k) number is K003419.

When did RCRP FLEX REAGENT CARTRIDGE receive FDA 510(k) clearance?

RCRP FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 2001-02-14, under 510(k) number K003419.

Who is the listed applicant for RCRP FLEX REAGENT CARTRIDGE?

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 RCRP FLEX REAGENT CARTRIDGE?

The FDA product code for RCRP FLEX REAGENT CARTRIDGE is DCN.

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Related Devices (Code: DCN)

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.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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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