Cozart Rapiscan Oral Fluid Drug Test - Opiate/Methadone
FDA 510(k) K020920 · Cozart Bioscience , Ltd.
510(k) numberK020920
Submission
- Device name
- Cozart Rapiscan Oral Fluid Drug Test - Opiate/Methadone
- Applicant
- Cozart Bioscience , Ltd.
Oxfordshire Ox14 4ru, GB - Received
- March 21, 2002
- Decision date
- November 5, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | Medtox Diagnostics, Inc. | 01/29/2026SE |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 01/23/2026SE |
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | Immunalysis Corporation | 09/11/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | Healgen Scientific,, LLC | 08/15/2025SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
More from Shanghai Accurature Diagnostics Co., 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 |
| K011131 | Methadone Microplate Eia Urine ApplicationDJR · Traditional | 07/31/2001SE |
Questions and answers
When was Cozart Rapiscan Oral Fluid Drug Test - Opiate/Methadone cleared by the FDA?
Cozart Rapiscan Oral Fluid Drug Test - Opiate/Methadone (K020920) received a 510(k) decision of Substantially Equivalent on November 5, 2002, 229 days after the submission was received.
What is the product code of K020920?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.