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Carbon Dioxide (co2), Scal, Nortrol And Abtrol

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K071340

by Thermofisher Scientific OY

Identifiers

510(k) Number
K071340 FDA 510(k)
FDA Product Code
KHS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1160 FDA 510(k)
Regulation Number
862.1160 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an enzymatic analyzer kit for measuring carbon dioxide (CO₂) levels in clinical chemistry. It employs enzymatic methods to quantify CO₂ concentrations in blood or other biological samples, supporting diagnostic assessments in metabolic and respiratory disorders.

The kit is supplied as a reagent set for in vitro diagnostic use, requiring no sterilization as it is intended for single-use. It is classified as a Class II medical device under FDA regulations and complies with In Vitro Diagnostic Device Directives (IVDD) and Regulations (IVDR). Multiple reference codes (e.g., 3016438761, 1000135102) identify specific reagent variants, each designed for compatibility with automated clinical chemistry analyzers.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Carbon | Journal | ScienceDirect.com by Elsevier

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Thermofisher Scientific OY

Sources (2)

  • FDA 510(k) K071340 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026