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

Name: FDA 510(k) clearance K171521
Creator: U.S. Food and Drug Administration
Published: 2018-02-16

Substantially Equivalent

DFI Co., Ltd.

FDA 510(k) clearance K171521 for DUS R-50S (Urine Chemistry system), Substantially Equivalent on 2018-02-16. Applicant: DFI Co., Ltd.. Device class: 2.

Clearance details

Applicant: DFI Co., Ltd.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2017-05-24
Decision date: 2018-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeongsangnam-Do, KR

Download summary PDF View on FDA.gov ↗

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