Acs Total Ige Immunoassay

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K920372 ↗

FDA Product Code

DGC

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ciba Corning Diagnostics Corp. →