s LDL-EX 開發藥品公司
K 號：K161679 · 2017-08-18
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器材摘要
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.
常見問題
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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官方來源
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