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

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)