Amylase (Kinetic) Reagent Set

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K915704 ↗

FDA Product Code

CJD

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Cholesterol Regeant Set

  Class I

  FDA 510(k) K914160 Active Cleared 30 Jan 1992

• Lipase Reagent Set

  Class I

  FDA 510(k) K915706 Active Cleared 18 Feb 1992

• Ammonia Reagent Set

  Class I

  FDA 510(k) K915707 Active Cleared 26 Feb 1992

• Glucose Reagent Set

  Class II

  FDA 510(k) K914159 Active Cleared 27 Jan 1992

• Uric Acid Reagent Set

  Class I

  FDA 510(k) K914158 Active Cleared 21 Feb 1992

• Acid Phosphatase Reagent Set

  Class II

  FDA 510(k) K902495 Active Cleared 16 Jul 1990

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