Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

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

510(k) Number

K243365 ↗

FDA Product Code

NGL

Models / Variants

Healgen Accurate Muti-Drug Urine Drug Screen Cup

Healgen Accurate Home Muti-Drug Urine Test Cup

FDA applicant

Healgen Scientific,, LLC

Device Class

Class II

Regulation

21 CFR Part 862.3650

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Healgen Scientific LLC →