Electrolyte Buffer A443-325, Electrolyte Reference Reagent A443-315, CO2 Acid Reagent A443-330, CO2 Alkaline Buffer A44

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K982501 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Calibration Solutions for Use on Electrolyte Instr

  Class II

  FDA 510(k) K925464 Active Cleared 13 Jan 1994

• Reagents for Hitachi Ise

  Class II

  FDA 510(k) K933383 Active Cleared 9 Mar 1994

• Alko Reagents for Baxter Paramax Chemistry System

  Class II

  FDA 510(k) K934607 Active Cleared 28 Mar 1994

• Ph Blood Gas Control Products

  Class II

  FDA 510(k) K884266 Active Cleared 16 May 1989

• Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak Systems

  Class II

  FDA 510(k) K960085 Active Cleared 11 Mar 1996

• THB Cal Standard for IL CO-Oximeters/Oximeters

  Class II

  FDA 510(k) K962864 Active Cleared 18 Dec 1996

See all devices from Alko Diagnostic Corp. →