Visualine Methadone Dipstriptest
FDA 510(k) K023856 · Sun Biomedical Laboratories, Inc.
510(k) numberK023856
Submission
- Device name
- Visualine Methadone Dipstriptest
- Applicant
- Sun Biomedical Laboratories, Inc.
Blackwood, NJ, US - Received
- November 19, 2002
- Decision date
- August 25, 2003
- 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 |
|---|---|---|
| K023648 | Visualine Cup IV for Drugs of Abuse Test for Qualitative Determination of Cocaine…LDJ · Traditional | 05/06/2003SE |
| K014089 | Visualine II (Also Known AS Sunline) BarituratesDIS · Traditional | 04/25/2002SE |
| K020136 | Visualine Barbiturates Dipstrip TestDIS · Traditional | 03/20/2002SE |
| K011499 | Visualine Amphetamine Dipstrip AssayDKZ · Traditional | 07/17/2001SE |
| K010177 | Visualine II (Also Known AS Sunline) Amphetamine AssayDKZ · Traditional | 05/17/2001SE |
| K993485 | Visualine V Drugs of Abuse Dipstrip Panel for Qualitative Determination of Cocaine…DIO · Traditional | 12/27/1999SE |
| K983790 | Visualine II (Also Known AS Sunline) PhencyclidineLCM · Traditional | 03/01/1999SE |
| K981314 | Visualine II (Also Known AS Sunline) MethadoneDJR · Traditional | 09/04/1998SE |
| K972032 | Visualine II MethamphetimineDKZ · Traditional | 08/12/1997SE |
| K963606 | Visualine Combo V (Cocaine/Thc) TestLDJ · Traditional | 10/30/1996SE |
Questions and answers
When was Visualine Methadone Dipstriptest cleared by the FDA?
Visualine Methadone Dipstriptest (K023856) received a 510(k) decision of Substantially Equivalent on August 25, 2003, 279 days after the submission was received.
What is the product code of K023856?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.