Total Bilirubin Reagent Set

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

510(k) Number

K821197 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Sgot Reagent Set

  Class II

  FDA 510(k) K821209 Active Cleared 14 Jul 1982

• Uric Acid Reagent Set(Enzymatic

  Class I

  FDA 510(k) K821214 Active Cleared 21 May 1982

• Serum Calcium Reagent Set

  Class II

  FDA 510(k) K821196 Active Cleared 13 Jul 1982

• Sgpt-UV Reagent Set

  Class I

  FDA 510(k) K821206 Active Cleared 22 Jul 1982

• Hemoglobin Reagent Set

  Class II

  FDA 510(k) K821202 Active Cleared 24 May 1982

• Serum Total Protein Reagent Set

  Class II

  FDA 510(k) K821210 Active Cleared 13 Jul 1982

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• What is the Total Bilirubin Reagent Set used for?

  The Total Bilirubin Reagent Set is a Diazo Colorimetry device used for measuring bilirubin levels in clinical chemistry testing. It is intended for laboratory use in determining total bilirubin concentrations.

• How is the Total Bilirubin Reagent Set supplied?

  The device is supplied as a reagent set. The provided data does not specify whether it is single-use or reusable, only that it is intended for laboratory use in clinical chemistry testing.

• What is the regulatory status of the Total Bilirubin Reagent Set?

  The device is regulated under FDA 510(k) clearance K821197, with a decision date of July 13, 1982. It is classified as Class II with special controls under regulation 862.1110.

• Who manufactures the Total Bilirubin Reagent Set?

  The Total Bilirubin Reagent Set is manufactured by Omega Medical Electronics, located at 803 N. Front St. Suite 3, McHenry, IL 60050, USA.