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S-TEST C02

by Alfa Wassermann Diagnostic Technologies, Inc. 510(k)

Active United States

510(k) K073223

Overview

The S-TEST C02 is an enzymatic, carbon-dioxide test system used for the quantitative, photometric measurement of total carbon dioxide in clinical chemistry. It is a reagent cartridge designed for in vitro diagnostic use.

The device is supplied as a proprietary reagent cartridge under the established name S-Test Carbon Dioxide (CO2) Reagent Cartridge. It received FDA 510(k) clearance (K073223) as a substantially equivalent device and is classified as a Class II medical device under regulation number 862.1160.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073223 Date26 Jun 2008ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KHS
Device Class
Class II
Regulation
21 CFR Part 862.1160
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the S-TEST C02 used for?

    The S-TEST C02 is used for the quantitative, photometric measurement of total carbon dioxide in clinical chemistry as an enzymatic, carbon-dioxide test system for in vitro diagnostic use.

  • How is the S-TEST C02 supplied?

    The S-TEST C02 is supplied as a proprietary reagent cartridge under the established name S-Test Carbon Dioxide (CO2) Reagent Cartridge, designed for use in clinical chemistry analyzers.

  • Is the S-TEST C02 a single-use or reusable device?

    The S-TEST C02 is a reagent cartridge intended for single-use in vitro diagnostic testing, as it is a consumable cartridge designed to be discarded after one test run to ensure accurate and reliable results.

  • What regulatory pathway was used for the S-TEST C02?

    The S-TEST C02 received FDA 510(k) clearance (K073223) as a substantially equivalent device, which is the regulatory pathway used to demonstrate its safety and effectiveness for in vitro diagnostic use.