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510(k) K181024

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips by DFI Co., Ltd. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2018
Date Received
April 18, 2018
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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