Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)

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

510(k) Number

K152269 ↗

FDA Product Code

DKZ

FDA applicant

Healgen Scientific,, LLC

Device Class

Class II

Regulation

21 CFR Part 862.3100

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Healgen URS Test Strips

  Class I

  FDA 510(k) K231045 Active Cleared 16 Jun 2023

• Healgen® URS Test Strips

  Class I

  FDA 510(k) K251800 Active Cleared 23 Dec 2025

• Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

  Class II

  FDA 510(k) K240949 Active Cleared 13 May 2024

• Healgen Thc One Step Marijuana Test, Healgen Mamp One Step Methamphetamine Test Open recall

  Class II

  FDA 510(k) K140546 Active Cleared 6 Jun 2014

• Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)

  Class II

  FDA 510(k) K150096 Active Cleared 4 Mar 2015

• Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

  Class II

  FDA 510(k) K251972 Active Cleared 15 Aug 2025

See all devices from Healgen Scientific LLC →