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FDA 510(k)

CRP-LATEX (II)X2 SEIKEN ASSAY KIT

K-Number: K030545 · 2003-06-02

ApplicantDenka Seiken Co., Ltd.
Decision Date2003-06-02
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CRP-LATEX (II)X2 SEIKEN ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Denka Seiken Co., Ltd.. It received FDA 510(k) clearance on 2003-06-02 under 510(k) number K030545. 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 CRP-LATEX (II)X2 SEIKEN ASSAY KIT?

CRP-LATEX (II)X2 SEIKEN ASSAY KIT is a medical device that received FDA 510(k) clearance on 2003-06-02. The listed applicant is Denka Seiken Co., Ltd.. The 510(k) number is K030545.

When did CRP-LATEX (II)X2 SEIKEN ASSAY KIT receive FDA 510(k) clearance?

CRP-LATEX (II)X2 SEIKEN ASSAY KIT received FDA 510(k) clearance on 2003-06-02, under 510(k) number K030545.

Who is the listed applicant for CRP-LATEX (II)X2 SEIKEN ASSAY KIT?

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

What is the FDA product code for CRP-LATEX (II)X2 SEIKEN ASSAY KIT?

The FDA product code for CRP-LATEX (II)X2 SEIKEN ASSAY KIT is DCK.

Related Clinical Trials

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Other records listing Denka Seiken Co., Ltd. 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.

K161679s LDL-EX SEIKENK060359ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10K043264LDL-EX SEIKEN ASSAY KITK041090HDL-EX SEIKEN ASSAY KITK030546CRP (II) CALIBRATORS

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

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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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