Test for Ketone in Urine(Acetoacetic Ac

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K801270 ↗

FDA Product Code

JIN

Device Class

Class I

Regulation

21 CFR Part 862.1435

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Modified Seralyzer Alt/Sgpt Reag. Strips & Module

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See all devices from Miles Laboratories, Inc. →