Digoxin Fpia Reagent Set and Calibrator Set

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K940569 ↗

FDA Product Code

KXT

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class I

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See all devices from Sigma Diagnostics, Inc. →