Corning 965 Carbon Dioxide Analyzer

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K811257 ↗

FDA Product Code

CHS

Device Class

Class II

Regulation

21 CFR Part 862.1160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Isoenzyme Serum Control

  Class I

  FDA 510(k) K780147 Active Cleared 23 Feb 1978

• Ria Kit, Immo Phase

  Class II

  FDA 510(k) K781953 Active Cleared 1 Feb 1979

• Vitamin B12 57CO/Folate 125I -

  Class II

  FDA 510(k) K840462 Active Cleared 25 Jun 1984

• Immo Phase, Thyroid Hormone

  Class II

  FDA 510(k) K781409 Active Cleared 27 Sep 1978

• Corning 60 Volt Power Supply

  Class I

  FDA 510(k) K801893 Active Cleared 16 Sep 1980

• Electrophoresis Power Supply Tester

  Class I

  FDA 510(k) K771322 Active Cleared 18 Oct 1977

See all devices from Corning Medical & Scientific →

• What clinical setting is the Corning 965 Carbon Dioxide Analyzer intended for, and what types of samples can it measure?

  The Corning 965 Carbon Dioxide Analyzer is designed specifically for clinical laboratory settings, where it measures carbon dioxide levels in blood or other biological samples. It uses a coulometric method to provide quantitative analytical results, making it useful for diagnostic purposes like assessing metabolic function, acid-base balance, or respiratory conditions.

• Is the Corning 965 Carbon Dioxide Analyzer a single-use or reusable device, and how does that affect its maintenance?

  The Corning 965 Carbon Dioxide Analyzer is a reusable instrument, meaning it is built for repeated use in clinical laboratories. Since it is not single-use, proper maintenance and calibration procedures must be followed to ensure accurate and reliable measurements over time. The manufacturer’s instructions (not provided here) would detail cleaning, servicing, and operational checks.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Corning 965 Carbon Dioxide Analyzer received FDA 510(k) clearance (K811257) under the Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for clinical chemistry applications in blood gas analysis.

• Does the Corning 965 Carbon Dioxide Analyzer require special storage conditions, and is sterility a consideration for its use?

  The provided data does not specify sterility requirements for the Corning 965 Carbon Dioxide Analyzer, nor does it detail storage conditions. However, since it is a reusable laboratory instrument, it should be stored in a clean, controlled environment to prevent contamination and ensure optimal performance. Users should refer to the manufacturer’s guidelines for proper handling and storage instructions.