Sigma Diagnostics Infinity Glucose Reagent, Models 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K001403 ↗

FDA Product Code

CFR

Models / Variants

17-25

17-100P

17-500P

17-2000P

18-20

18-100P

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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