Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992798 ↗

FDA Product Code

CDO

Models / Variants

684-25

684-100P

684-500P

684-2000P

683-20

683-100P

Device Class

Class I

Regulation

21 CFR Part 862.1775

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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