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FDA 510(k)

HDL-EX SEIKEN ASSAY KIT

K-Number: K041090 · 2004-10-29

ApplicantDenka Seiken Co., Ltd.
Decision Date2004-10-29
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL-EX 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 2004-10-29 under 510(k) number K041090. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDL-EX SEIKEN ASSAY KIT?

HDL-EX SEIKEN ASSAY KIT is a medical device that received FDA 510(k) clearance on 2004-10-29. The listed applicant is Denka Seiken Co., Ltd.. The 510(k) number is K041090.

When did HDL-EX SEIKEN ASSAY KIT receive FDA 510(k) clearance?

HDL-EX SEIKEN ASSAY KIT received FDA 510(k) clearance on 2004-10-29, under 510(k) number K041090.

Who is the listed applicant for HDL-EX 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 HDL-EX SEIKEN ASSAY KIT?

The FDA product code for HDL-EX SEIKEN ASSAY KIT is LBS.

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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 KITK030546CRP (II) CALIBRATORSK030545CRP-LATEX (II)X2 SEIKEN ASSAY KIT

Related Devices (Code: LBS)

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.

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation

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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