System 5 - Semi-Automated Clin. Analy

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K760749 ↗

FDA Product Code

JJC

Device Class

Class I

Regulation

21 CFR Part 862.2150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Gilford Instrument Laboratories, Inc. →