Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)

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

510(k) Number

K143187 ↗

FDA Product Code

DJG

FDA applicant

Healgen Scientific,, LLC

Device Class

Class II

Regulation

21 CFR Part 862.3650

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 →