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510(k) K101673

URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 by Teco Diagnostics — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2011
Date Received
June 15, 2010
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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