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510(k) K141289

TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS by Teco Diagnostics — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2015
Date Received
May 19, 2014
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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