Amylase Reagent Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812447 ↗

FDA Product Code

KHM

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Gram Stain Kit

  Class I

  FDA 510(k) K781584 Active Cleared 10 Oct 1978

• Acid Fast Kit

  Class I

  FDA 510(k) K781643 Active Cleared 3 Oct 1978

• Sodium Chloride, 0.85%

  Not classified

  FDA 510(k) K781734 Active Cleared 24 Oct 1978

• Papanicolaou Stain :ea-50:

  Class I

  FDA 510(k) K781583 Active Cleared 10 Oct 1978

• Papanicolaou Stian Og-6

  Class I

  FDA 510(k) K781588 Active Cleared 10 Oct 1978

• Wright Stain Pack

  Not classified

  FDA 510(k) K791658 Active Cleared 17 Oct 1979

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