FDA 510(k), K171521, DUS R-50S (Urine Chemistry system)

510(K) Number: K171521
Device Name: DUS R-50S (Urine Chemistry system)
Manufacturer: DFI Co., Ltd.
Device Classification Name: method, enzymatic, glucose (urinary, non-quantitative)
Regulation Number: 862.1340
Classification Product Code: JIL
Date Received: 05/24/2017
Decision Date: 02/16/2018
Regulation Medical Specialty: Clinical Chemistry

534 pages (894 of 1,428 original pages are fully redacted)