Cozart Eia Opiates Oral Fluid Kit
FDA 510(k) K024339 · Cozart Bioscience , Ltd.
510(k) numberK024339
Submission
- Device name
- Cozart Eia Opiates Oral Fluid Kit
- Applicant
- Cozart Bioscience , Ltd.
Oxfordshire Ox14 4ru, GB - Received
- December 27, 2002
- Decision date
- April 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIG – Cholinesterase Test Paper
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3240
- Specialty
- Clinical Toxicology
More from Cozart Bioscience , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K033743 | Cozart Eia Amphetamines Oral Fluid Microplate KitDKZ · Traditional | 06/03/2004SE |
| K021944 | Cozart Eia Cotinine Urine KitMKU · Traditional | 05/14/2003SE |
| K030234 | Cozart Eia Cocaine Oral Fliud KitDIO · Traditional | 04/28/2003SE |
| 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 Opiates Oral Fluid Kit cleared by the FDA?
Cozart Eia Opiates Oral Fluid Kit (K024339) received a 510(k) decision of Substantially Equivalent on April 7, 2003, 101 days after the submission was received.
What is the product code of K024339?
The FDA product code is DIG – Cholinesterase Test Paper, a Class I (low risk) device regulated under 21 CFR 862.3240.