FDA 510(k)

s LDL-EX SEIKEN

Número K: K161679 · 2017-08-18

Data da decisão2017-08-18

Código do produtoPYP

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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