URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer— 510(k) K182038

Substantially Equivalent

Yd Diagnostics Corporation

FDA 510(k) clearance K182038 for URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer, Substantially Equivalent on 2018-12-10. Applicant: Yd Diagnostics Corporation.

Clearance details

Applicant: Yd Diagnostics Corporation
Product code: Code JFY
Advisory panel: Clinical Chemistry
Date received: 2018-07-30
Decision date: 2018-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

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