Thyro-Zyme-T4 Assay Kit

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K780401 ↗

FDA Product Code

CDX

Device Class

Class II

Regulation

21 CFR Part 862.1700

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Chemistry, Coulter

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