HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST— 510(k) K140546

Clearance details

Applicant

Healgen Scientific,, LLC

Product code

Code LDJ

Device class

Class 2

Regulation

21 CFR 862.3870

Advisory panel

Clinical Toxicology

Date received

2014-03-04

Decision date

2014-06-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gaithersburg, MD, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140546.