Bun Reagent Kit #88108

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K800616 ↗

FDA Product Code

CDS

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Astra-T Calcium Reagent

  Class II

  FDA 510(k) K820090 Active Cleared 28 Jan 1982

• Cholar Produ&T #17010

  Class I

  FDA 510(k) K771731 Active Cleared 25 Oct 1977

• Direct Bilirubin Reagent

  Class II

  FDA 510(k) K841572 Active Cleared 16 May 1984

• Cholorde Reagent

  Class II

  FDA 510(k) K791690 Active Cleared 17 Sep 1979

• Hilar

  Class II

  FDA 510(k) K782094 Active Cleared 17 Jan 1979

• Ast Reagent Cartridge

  Class II

  FDA 510(k) K861283 Active Cleared 28 Apr 1986

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