COZART EIA COCAINE ORAL FLIUD KIT— 510(k) K030234

Name: FDA 510(k) clearance K030234
Creator: U.S. Food and Drug Administration
Published: 2003-04-28

Substantially Equivalent

Cozart Bioscience , Ltd.

FDA 510(k) clearance K030234 for COZART EIA COCAINE ORAL FLIUD KIT, Substantially Equivalent on 2003-04-28. Applicant: Cozart Bioscience , Ltd.. Device class: 2.

Clearance details

Applicant: Cozart Bioscience , Ltd.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2003-01-23
Decision date: 2003-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abingdon,Oxfordshire, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIO

view all

K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System2022-01-27
K211973 — DRI Cocaine Metabolite Assay2021-09-24
K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay2020-03-12
K181499 — DRI Cocaine Metabolite Assay2018-07-06
K170293 — Emit II Plus Cocaine Metabolite Assay2017-10-25

More clearances from Cozart Bioscience , Ltd.

view all

K033743 — COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT2004-06-03
K021944 — COZART EIA COTININE URINE KIT2003-05-14
K024339 — COZART EIA OPIATES ORAL FLUID KIT2003-04-07
K020920 — COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE2002-11-05
K011131 — METHADONE MICROPLATE EIA URINE APPLICATION2001-07-31

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