Membrane Kits-KC1, CO2 & 02 for Instrument-Lab

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

510(k) Number

K844781 ↗

FDA Product Code

CHL

Device Class

Class II

Regulation

21 CFR Part 862.1120

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Pump Tube Sets for Hema-Tek I & II Slide Stainers

  Class I

  FDA 510(k) K850333 Active Cleared 27 Feb 1985

• Potassium Analyzer-Sodium/Electrolyte

  Class II

  FDA 510(k) K830588 Active Cleared 27 Apr 1983

• Electrolyte Standard - Corning Nalk Ise

  Class II

  FDA 510(k) K830589 Active Cleared 27 Apr 1983

• Supplies for Instrumentation Lab Flame

  Class I

  FDA 510(k) K840530 Active Cleared 30 Mar 1984

• Shaban 9865 IL#78637 Junction Bloc

  Class I

  FDA 510(k) K833804 Active Cleared 13 Jan 1984

• External Standards-Sodiumnpotassium

  Class II

  FDA 510(k) K820700 Active Cleared 1 Apr 1982

See all devices from Shaban Mfg. Co. →

• What is the Membrane Kits-Kc1 used for?

  The Membrane Kits-Kc1 is used to measure CO2 and O2 levels in blood samples for diagnostic purposes in clinical chemistry applications.

• Is the Membrane Kits-Kc1 reusable?

  No, the Membrane Kits-Kc1 is a single-use device and is not reusable.

• How is the Membrane Kits-Kc1 stored?

  The Membrane Kits-Kc1 is stored at room temperature.

• What is the regulatory classification of the Membrane Kits-Kc1?

  The Membrane Kits-Kc1 is classified as a class 2 device with a regulation number of 862.1120.