Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia Jo-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01

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

510(k) Number

K083117 ↗

FDA Product Code

LKO

Models / Variants

14-5511-01

14-5506-01

14-5507-01

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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