Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT

FDA 510(k) K223162 · Healgen Scientific,, LLC

Substantially Equivalent

510(k) numberK223162

Submission

Device name
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
Applicant
Healgen Scientific,, LLC
Bellaire, TX, US
Received
October 7, 2022
Decision date
March 17, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LDJ – Enzyme Immunoassay, Cannabinoids
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3870
Specialty
Clinical Toxicology

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K140546Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestLDJ · Traditional Healgen Scientific,, LLC06/06/2014SE
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Questions and answers

When was Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT cleared by the FDA?

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT (K223162) received a 510(k) decision of Substantially Equivalent on March 17, 2023, 161 days after the submission was received.

What is the product code of K223162?

The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.