Lipase Determination

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K800550 ↗

FDA Product Code

CFG

Device Class

Class I

Regulation

21 CFR Part 862.1465

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Cholesterol Reagent Set

  Class I

  FDA 510(k) K770998 Active Cleared 2 Jun 1977

• 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

• Hemoglobin Analyzer & Perform. Check Set

  Class II

  FDA 510(k) K771101 Active Cleared 21 Jul 1977

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