Urea Nitrogen (Enzymatic) Determination

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K822154 ↗

FDA Product Code

CDN

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Cholesterol Reagent Set

  Class I

  FDA 510(k) K770998 Active Cleared 2 Jun 1977

• Lipase Determination

  Class I

  FDA 510(k) K800550 Active Cleared 2 Apr 1980

• Total Thyroxine (Ria) Reagent Set

  Class II

  FDA 510(k) K770940 Active Cleared 22 Jun 1977

• Accessory Hdl Cholesterol Reagent Set

  Class I

  FDA 510(k) K780638 Active Cleared 26 May 1978

• (Ast) or (Alt) UV Determ. Phy. Phos.

  Class II

  FDA 510(k) K781020 Active Cleared 27 Jul 1978

• Clinical Spectrophotometer

  Class I

  FDA 510(k) K760672 Active Cleared 29 Oct 1976

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