Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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.

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.

↑