AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE— 510(k) K012484

Name: FDA 510(k) clearance K012484
Creator: U.S. Food and Drug Administration
Published: 2001-11-30

Substantially Equivalent

Ameditech, Inc.

FDA 510(k) clearance K012484 for AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE, Substantially Equivalent on 2001-11-30. Applicant: Ameditech, Inc.. Device class: 2.

Clearance details

Applicant: Ameditech, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2001-08-02
Decision date: 2001-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, 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 Ameditech, Inc.

view all

K113501 — AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)2011-12-05
K113046 — AMEDITECH IMMUTEST MILTI-DRUG SCREEN2011-11-10
K063015 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC1502006-12-20
K053175 — AMEDITECH DRUGSMARTCUP2005-12-08
K050186 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III2005-03-04

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