Ultra-Violet Bun Reagent Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K851513 ↗

FDA Product Code

CDQ

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Urea Nitrogen, Kinetic

  Class II

  FDA 510(k) K810087 Active Cleared 26 Feb 1981

• Uric Acid (Tptz) Colorinmetric

  Class I

  FDA 510(k) K810088 Active Cleared 28 Jan 1981

• Acetaminophen(Paracetamol

  Class II

  FDA 510(k) K832567 Active Cleared 12 Sep 1983

• Ldh-L Liquid Enzymatic, Kinetic Kit

  Class II

  FDA 510(k) K810083 Active Cleared 28 Jan 1981

• Enzymatic Alpha-Amylase Reagent Kit

  Class II

  FDA 510(k) K860245 Active Cleared 14 Mar 1986

• Albumin Reagent Kit

  Class II

  FDA 510(k) K860213 Active Cleared 11 Feb 1986

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