Ontrak Testtcup Collection/Urinalysis Panel

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K964422 ↗

FDA Product Code

DIF

Device Class

Class I

Regulation

21 CFR Part 862.3280

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

  FDA 510(k) K962411 Active Cleared 7 Oct 1996

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