Visualine Cup IV for Drugs of Abuse Test for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetami
FDA 510(k) K023648 · Sun Biomedical Laboratories, Inc.
510(k) numberK023648
Submission
- Device name
- Visualine Cup IV for Drugs of Abuse Test for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetami
- Applicant
- Sun Biomedical Laboratories, Inc.
Blackwood, NJ, US - Received
- October 30, 2002
- Decision date
- May 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 10/11/2019SE |
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| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…LDJ · Traditional | Immunalysis Corporation | 06/05/2015SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | Lin-Zhi International, Inc. | 05/28/2015SE |
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional | Polymed Therapeutics, Inc. | 09/25/2014SE |
| K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestLDJ · Traditional | Healgen Scientific,, LLC | 06/06/2014SE |
More from Healgen Scientific,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K023856 | Visualine Methadone DipstriptestDJR · Traditional | 08/25/2003SE |
| 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 Cup IV for Drugs of Abuse Test for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetami cleared by the FDA?
Visualine Cup IV for Drugs of Abuse Test for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetami (K023648) received a 510(k) decision of Substantially Equivalent on May 6, 2003, 188 days after the submission was received.
What is the product code of K023648?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.