Carbon Dioxide Reagent Set— 510(k) K170200

Name: FDA 510(k) clearance K170200
Creator: U.S. Food and Drug Administration
Published: 2017-06-01

Substantially Equivalent

Teco Diagnostics, Inc.

FDA 510(k) clearance K170200 for Carbon Dioxide Reagent Set, Substantially Equivalent on 2017-06-01. Applicant: Teco Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Teco Diagnostics, Inc.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 2017-01-23
Decision date: 2017-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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K120765 — VITROS CHEMISTRY PRODUCTS ECO2 SLIDES2012-10-24

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