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510(k) K131600

URS-2GP (GLUCOSE PROTEIN) URINE STRIPS by Teco Diagnostics — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2014
Date Received
June 3, 2013
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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