Epsilon Ige Test Kit

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K831987 ↗

FDA Product Code

DGO

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Immage Immunochemistry System Ceruloplasmin (Cer) Reagent

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• Immage Immunochemistry System Haptoglobin (Hpt) Reagent

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