TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS— 510(k) K141289

Name: FDA 510(k) clearance K141289
Creator: U.S. Food and Drug Administration
Published: 2015-07-24

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K141289 for TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS, Substantially Equivalent on 2015-07-24. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2014-05-19
Decision date: 2015-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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