King Diagnostics Sodium/Potassium Standard

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

510(k) Number

K920809 ↗

FDA Product Code

JIS

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• King Diagnostics Phosphorus Test

  Class I

  FDA 510(k) K811749 Active Cleared 10 Jul 1981

• Potassium Test

  Class II

  FDA 510(k) K811661 Active Cleared 25 Jun 1981

• Acid Phosphatase Test

  Class II

  FDA 510(k) K873726 Active Cleared 27 Jan 1988

• Calibration Kit

  Class II

  FDA 510(k) K882220 Active Cleared 2 Aug 1988

• King Diagnostics Ldh Test

  Class II

  FDA 510(k) K862306 Active Cleared 19 Aug 1986

• Albumin Test

  Class II

  FDA 510(k) K811662 Active Cleared 25 Jun 1981

See all devices from King Diagnostics, Inc. →

• What is the King Diagnostics Sodium/Potassium Standard used for?

  It is a calibrator, primary, used in clinical chemistry for the calibration of laboratory equipment measuring sodium and potassium levels, ensuring accurate and traceable results in diagnostic testing.

• Is the King Diagnostics Sodium/Potassium Standard sterile or non-sterile?

  The device is supplied as a non-sterile laboratory reagent, as stated in the device data, and its sterility status depends on the specific formulation and handling procedures.

• Can the King Diagnostics Sodium/Potassium Standard be reused?

  It is intended for single-use or reusable laboratory reagent depending on formulation and handling, meaning reuse is possible only if the specific formulation and handling procedures allow it.

• What regulatory pathway was used for the King Diagnostics Sodium/Potassium Standard?

  It was cleared by the FDA under 510(k) K920809, classified as a Class II device with product code JIS, and is subject to special controls under regulation 862.1150 for clinical chemistry calibrators.