Uric Acid Test Item Number 65422

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K894287 ↗

FDA Product Code

KNK

Device Class

Class I

Regulation

21 CFR Part 862.1775

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Systemate (Tm) Alanine Transferase (Alt)

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• Systemate Ldh, 67210

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