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FDA 510(k)

s LDL-EX SEIKEN

K-Number: K161679 · 2017-08-18

ApplicantDenka Seiken Co., Ltd.
Decision Date2017-08-18
Product CodePYP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

s LDL-EX SEIKEN 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 2017-08-18 under 510(k) number K161679. The device is classified under product code PYP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the s LDL-EX SEIKEN?

s LDL-EX SEIKEN is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Denka Seiken Co., Ltd.. The 510(k) number is K161679.

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

s LDL-EX SEIKEN received FDA 510(k) clearance on 2017-08-18, under 510(k) number K161679.

Who is the listed applicant for s LDL-EX SEIKEN?

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 s LDL-EX SEIKEN?

The FDA product code for s LDL-EX SEIKEN is PYP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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.

K060359ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10K043264LDL-EX SEIKEN ASSAY KITK041090HDL-EX SEIKEN ASSAY KITK030546CRP (II) CALIBRATORSK030545CRP-LATEX (II)X2 SEIKEN ASSAY KIT

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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