Methadone Microplate Eia Urine Application
FDA 510(k) K011131 · Cozart Bioscience , Ltd.
510(k) numberK011131
Submission
- Device name
- Methadone Microplate Eia Urine Application
- Applicant
- Cozart Bioscience , Ltd.
Oxfordshire Ox14 4ru, GB - Received
- April 13, 2001
- Decision date
- July 31, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJR – Enzyme Immunoassay, Methadone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3620
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | Lin-Zhi International, Inc. | 10/04/2019SE |
| K182779 | ARK EDDP AssayDJR · Traditional | Ark Diagnostics, Inc. | 11/21/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | Lin-Zhi International, Inc. | 06/26/2017SE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…DJR · Traditional | W.H.P.M., Inc. | 08/17/2016SE |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJR · Traditional | Assure Tech. Co., Ltd. | 10/05/2015SE |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…DJR · Traditional | Immunalysis Corporation | 07/24/2015SE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | W.H.P.M., Inc. | 06/29/2015SE |
| K131232 | Wondfo Methadone Urine Test (MTD 200), Wondofo Morphine Urine Test (Mop 100)DJR · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/31/2013SE |
| K092272 | Randox Methadone AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/18/2010SE |
| K092258 | Randox Metabolite (Eddp) AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/09/2010SE |
More from Randox Laboratories, 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 |
| K024339 | Cozart Eia Opiates Oral Fluid KitDIG · Traditional | 04/07/2003SE |
| K020920 | Cozart Rapiscan Oral Fluid Drug Test - Opiate/MethadoneDJG · Traditional | 11/05/2002SE |
Questions and answers
When was Methadone Microplate Eia Urine Application cleared by the FDA?
Methadone Microplate Eia Urine Application (K011131) received a 510(k) decision of Substantially Equivalent on July 31, 2001, 109 days after the submission was received.
What is the product code of K011131?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.