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510(k) K171521

DUS R-50S (Urine Chemistry system) by DFI Co., Ltd. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2018
Date Received
May 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

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