Enzymatic Urea Nitrogen Reagent Set Revi

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

510(k) Number

K800719 ↗

FDA Product Code

CDQ

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Auto Enzymatic Cholesterol

  Class I

  FDA 510(k) K790947 Active Cleared 28 Jun 1979

• Creatine Phosphokinase (Cpk) Reagent Set

  Class II

  FDA 510(k) K792533 Active Cleared 11 Jan 1980

• Rapid Chem Analyzer II

  Class I

  FDA 510(k) K830095 Active Cleared 28 Jan 1983

• Uric Acid Reference Sera

  Class II

  FDA 510(k) K780447 Active Cleared 22 Jun 1978

• Serum Glutamic Oxaloacetic Transaminase

  Class II

  FDA 510(k) K780013 Active Cleared 30 Jan 1978

• Ldh (UV Kinetic)

  Class II

  FDA 510(k) K781128 Active Cleared 10 Aug 1978

See all devices from Macomb Chemical Co. →

• What is the Enzymatic Urea Nitrogen Reagent Set REVI used for?

  It is used to measure urea nitrogen, an end-product of nitrogen metabolism, in whole blood, serum, plasma, and urine. These measurements help assess renal function and metabolic status in clinical chemistry settings.

• How is the Enzymatic Urea Nitrogen Reagent Set REVI supplied and intended for use?

  The reagent set is supplied for in vitro diagnostic use in laboratory settings and is intended for single use only. It is non-sterile and requires storage under conditions specified by the manufacturer.

• What regulatory pathway was used for the Enzymatic Urea Nitrogen Reagent Set REVI?

  The device was cleared under the FDA 510(k) process with submission number K800719, classified as a Class II device under product code CDQ and regulation number 862.1770.