Amylase Procedure

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K863588 ↗

FDA Product Code

JFJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Hemoglobin Controls

  Class II

  FDA 510(k) K790457 Active Cleared 4 Apr 1979

• Gamma Glutamyl Transferase Procedure

  Class I

  FDA 510(k) K863586 Active Cleared 3 Oct 1986

• Direct Bilirubin Procedure

  Class II

  FDA 510(k) K881166 Active Cleared 28 Apr 1988

• Data-Zyme Glucose Hexokinase UV

  Class II

  FDA 510(k) K801052 Active Cleared 23 May 1980

• Data-Zyme Triglyceride Procedure

  Class I

  FDA 510(k) K780379 Active Cleared 12 May 1978

• Magnesium Procedure

  Class I

  FDA 510(k) K861668 Active Cleared 27 May 1986

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