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FDA 510(k)

LDL-EX SEIKEN ASSAY KIT

K-Number: K043264 · 2005-01-26

ApplicantDenka Seiken Co., Ltd.
Decision Date2005-01-26
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LDL-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 2005-01-26 under 510(k) number K043264. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDL-EX SEIKEN ASSAY KIT?

LDL-EX SEIKEN ASSAY KIT is a medical device that received FDA 510(k) clearance on 2005-01-26. The listed applicant is Denka Seiken Co., Ltd.. The 510(k) number is K043264.

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

LDL-EX SEIKEN ASSAY KIT received FDA 510(k) clearance on 2005-01-26, under 510(k) number K043264.

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

The FDA product code for LDL-EX SEIKEN ASSAY KIT is MRR.

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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, 8K41-10K041090HDL-EX SEIKEN ASSAY KITK030546CRP (II) CALIBRATORSK030545CRP-LATEX (II)X2 SEIKEN ASSAY KIT

Related Devices (Code: MRR)

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.

K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.K210801AXINON® LDL-p Test SystemNumares AGK161691Direct LDL Cholesterol (LDL)Randox Laboratories LimitedK091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022Alfa Wassermann, Inc.K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMedica Corp.K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLiposcience

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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