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FDA 510(k) K141289, TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS, by Teco Diagnostics

FDA 510(k) K141289, TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS, by Teco Diagnostics

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510(K) Number: K141289
Device Name: TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
Manufacturer: Teco Diagnostics
Device Classification Name: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation Number: JIL
Classification Product Code: KXA
Date Received: 05/19/2014
Decision Date: 07/24/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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