Analyte Carbon Dioxide Assayed on Technicon Ra

No FDA recalls on record, checked 22 Oct 2026.

Full name

Analyte Carbon Dioxide Assayed on Technicon Ra(Tm)

510(k) Number

K880609 ↗

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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See all devices from Technicon Instruments Corp. →

• What is the intended use of the Analyte Carbon Dioxide assay?

  This device is an enzymatic test system intended for the measurement of bicarbonate and carbon dioxide levels in human plasma, serum, and whole blood samples.

• What type of medical device is this system?

  The system is classified as a clinical chemistry system under regulation number 862.1160. It is a class 2 medical device that has received FDA 510(k) clearance.

• Which instrument is this assay designed to be used with?

  This specific assay is designed for use on the Technicon Ra clinical chemistry system to ensure accurate measurement of carbon dioxide and bicarbonate levels.