AMPHETAMINE/METHAMPHETAMINE— 510(k) K012998

Name: FDA 510(k) clearance K012998
Creator: U.S. Food and Drug Administration
Published: 2002-03-13

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K012998 for AMPHETAMINE/METHAMPHETAMINE, Substantially Equivalent on 2002-03-13. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LAF
Device class: Class 2
Regulation: 21 CFR 862.3610
Advisory panel: Clinical Toxicology
Date received: 2001-09-06
Decision date: 2002-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LAF

view all

K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay2021-12-22
K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair2021-12-15
K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers2020-07-31
K170222 — Rapid Tox Cup II2017-08-15
K153693 — Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators2016-03-18

More clearances from Abbott Laboratories

view all

K252424 — Anti-HCV Next2026-04-28
K243500 — ARCHITECT iGentamicin2025-07-09
K243168 — Alinity i Rubella IgG2025-06-20
K243283 — Alinity h-series System2025-02-20
K233932 — Alinity i Toxo IgM2024-08-30

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