Cm-Trisacryl M Deae-Trisacryl M

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K842028 ↗

FDA Product Code

KEA

Device Class

Class I

Regulation

21 CFR Part 862.2230

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Engstom Edith

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• Delfia(Tm) Ferritin Kit

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