Digoxin Assay for the Tecchnicon Ra/Opera Systems in-Vitro Diagnostic Systems

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K951631 ↗

FDA Product Code

LFM

Device Class

Class II

Regulation

21 CFR Part 862.3300

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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