Cozart Eia Amphetamines Oral Fluid Microplate Kit
FDA 510(k) K033743 · Cozart Bioscience , Ltd.
510(k) numberK033743
Submission
- Device name
- Cozart Eia Amphetamines Oral Fluid Microplate Kit
- Applicant
- Cozart Bioscience , Ltd.
Abingdon,Oxfordshire, GB - Received
- November 28, 2003
- Decision date
- June 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021944 | Cozart Eia Cotinine Urine KitMKU · Traditional | 05/14/2003SE |
| K030234 | Cozart Eia Cocaine Oral Fliud KitDIO · Traditional | 04/28/2003SE |
| K024339 | Cozart Eia Opiates Oral Fluid KitDIG · Traditional | 04/07/2003SE |
| K020920 | Cozart Rapiscan Oral Fluid Drug Test - Opiate/MethadoneDJG · Traditional | 11/05/2002SE |
| K011131 | Methadone Microplate Eia Urine ApplicationDJR · Traditional | 07/31/2001SE |
Questions and answers
When was Cozart Eia Amphetamines Oral Fluid Microplate Kit cleared by the FDA?
Cozart Eia Amphetamines Oral Fluid Microplate Kit (K033743) received a 510(k) decision of Substantially Equivalent on June 3, 2004, 188 days after the submission was received.
What is the product code of K033743?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.