SIGMA DIAGNOSTICS INFINITY BUN REAGENT - 64-100P

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992800 ↗

FDA Product Code

CDQ

Models / Variants

63-25

63-100P

63-500P

63-2000P

64-20

64-100P

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Aspartate Aminotransferase Procedure No.. 58-Uv

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• Ethanol Controls, Urine, Levels 1, II, and III

  Class I

  FDA 510(k) K932067 Active Cleared 16 Jun 1993

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