SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT - Models 51-100P

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992801 ↗

FDA Product Code

CIT

Models / Variants

51-25

Sigma Diagnostics Infinity Ast Reagent

Models 51-100P

51-500P

5

Device Class

Class II

Regulation

21 CFR Part 862.1100

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Sigma Diagnostics, Inc. →