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FDA 510(k)

URiSCAN 10ACR 尿試紙於URiSCAN Optima 尿分析儀上

K 號：K182038 · 2018-12-10

申請人Yd Diagnostics Corporation
決定日期2018-12-10
產品代碼JFY
諮詢委員會CH
決定相當於

器材摘要

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Yd Diagnostics Corporation. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K182038. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer?

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Yd Diagnostics Corporation. The 510(k) number is K182038.

When did URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer receive FDA 510(k) clearance?

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer received FDA 510(k) clearance on 2018-12-10, under 510(k) number K182038.

Who is the listed applicant for URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer?

The FDA 510(k) record lists Yd Diagnostics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer?

The FDA product code for URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer is JFY.

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