Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set— 510(k) K143500

Name: FDA 510(k) clearance K143500
Creator: U.S. Food and Drug Administration
Published: 2015-02-06

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K143500 for Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set, Substantially Equivalent on 2015-02-06. Applicant: Immunalysis Corporation. Device class: 2.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2014-12-10
Decision date: 2015-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, 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 Immunalysis Corporation

view all

K252520 — SEFRIA Hydrocodone Oral Fluid2025-09-11
K232898 — Quantisal Oral Fluid Collection Device2023-11-21
K223781 — Quantisal II Oral Fluid Collection Device2023-07-28
K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay2021-12-22
K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay2021-12-22

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