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FDA 510(k) K182038, URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer, by Yd Diagnostics Corporation

FDA 510(k) K182038, URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer, by Yd Diagnostics Corporation

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$3,462.13 USD
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510(K) Number: K182038
Device Name: URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
Manufacturer: Yd Diagnostics Corporation
Device Classification Name: enzymatic method, creatinine
Regulation Number: 862.1225
Classification Product Code: JFY
Date Received: 07/30/2018
Decision Date: 12/10/2018
Regulation Medical Specialty: Clinical Chemistry

2084 pages (1,570 of 3,654 original pages are fully redacted)
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