URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10— 510(k) K101673

Name: FDA 510(k) clearance K101673
Creator: U.S. Food and Drug Administration
Published: 2011-02-04

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K101673 for URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10, Substantially Equivalent on 2011-02-04. 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: 2010-06-15
Decision date: 2011-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIL

view all

K193514 — AUTION MAX AX-4060 Urinalysis System2023-04-13
K183432 — cobas u 601 urinalysis test system2019-05-07
K173327 — DIP/U.S. Urine Analysis Test System2018-07-18
K180356 — inui In-Home Urine Analysis Test System2018-05-25
K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips2018-05-23

More clearances from Teco Diagnostics

view all

K170118 — Scanostics UTI Check Application Test System2017-09-21
K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS2015-07-24
K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS2014-05-29
K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST2011-10-04
K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS2011-02-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.