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FDA 510(k)

CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

K-Number: K011958 · 2001-12-04

ApplicantDenka Seiken'S
Decision Date2001-12-04
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Denka Seiken'S. It received FDA 510(k) clearance on 2001-12-04 under 510(k) number K011958. 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 CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT?

CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT is a medical device that received FDA 510(k) clearance on 2001-12-04. The listed applicant is Denka Seiken'S. The 510(k) number is K011958.

When did CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT receive FDA 510(k) clearance?

CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT received FDA 510(k) clearance on 2001-12-04, under 510(k) number K011958.

Who is the listed applicant for CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT?

The FDA 510(k) record lists Denka Seiken'S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT?

The FDA product code for CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT is DCN.

Related Clinical Trials

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.

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Other records listing Denka Seiken'S as applicant

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.

K011400MRSA-SCREENK013359LP(A)-LATEX SEIKEN ASSAY KITK981734VTEC-RPLA SEIKEN

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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