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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 a medical device manufactured by Denka Seiken Co., Ltd.. It received FDA 510(k) clearance on 2017-08-18 under approval 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. It is manufactured by Denka Seiken Co., Ltd.. The 510(k) number is K161679.

When was s LDL-EX SEIKEN approved by the FDA?

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

What company makes s LDL-EX SEIKEN?

s LDL-EX SEIKEN is manufactured by Denka Seiken Co., Ltd..

What is the FDA product code for s LDL-EX SEIKEN?

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

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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