Cleared Traditional

TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS

K141289 · Teco Diagnostics · Chemistry
Jul 2015
Decision
431d
Days
Class 2
Risk

About This 510(k) Submission

K141289 is an FDA 510(k) clearance for the TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on July 24, 2015, 431 days after receiving the submission on May 19, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K141289 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2014
Decision Date July 24, 2015
Days to Decision 431 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340

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