URITEK TC-201 URINE CHEMISTRY TEST SYSTEM— 510(k) K160372

Name: FDA 510(k) clearance K160372
Creator: U.S. Food and Drug Administration
Published: 2016-07-22

Substantially Equivalent

Teco Diagnostics, Inc.

FDA 510(k) clearance K160372 for URITEK TC-201 URINE CHEMISTRY TEST SYSTEM, Substantially Equivalent on 2016-07-22. Applicant: Teco Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Teco Diagnostics, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2016-02-10
Decision date: 2016-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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