Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)— 510(k) K152269

Name: FDA 510(k) clearance K152269
Creator: U.S. Food and Drug Administration
Published: 2015-09-09

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K152269 for Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card), Substantially Equivalent on 2015-09-09. Applicant: Healgen Scientific,, LLC. Device class: 2.

Clearance details

Applicant: Healgen Scientific,, LLC
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2015-08-11
Decision date: 2015-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellaire, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DKZ

view all

K240670 — DRI Ecstasy Plus Assay2024-10-30
K233019 — AllTest Multi-Drug Rapid Test Cup +3 more2023-12-13
K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard2023-05-19
K200363 — Quidel Triage® TOX Drug Screen, 946002020-03-11
K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel2019-10-03

More clearances from Healgen Scientific,, LLC

view all

K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test2026-04-13
K253705 — Healgen® Accurate Oral Fluid Drug Test2026-03-16
K252523 — Healgen® Accurate Oral Fluid Drug Test COT/THC2026-02-12
K251800 — Healgen® URS Test Strips2025-12-23
K253567 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card2025-12-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.