Visualine II (Also Known AS Sunline) Amphetamine Assay
FDA 510(k) K010177 · Sun Biomedical Laboratories, Inc.
510(k) numberK010177
Submission
- Device name
- Visualine II (Also Known AS Sunline) Amphetamine Assay
- Applicant
- Sun Biomedical Laboratories, Inc.
Blackwood, NJ, US - Received
- January 18, 2001
- Decision date
- May 17, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023856 | Visualine Methadone DipstriptestDJR · Traditional | 08/25/2003SE |
| 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 |
| 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 II (Also Known AS Sunline) Amphetamine Assay cleared by the FDA?
Visualine II (Also Known AS Sunline) Amphetamine Assay (K010177) received a 510(k) decision of Substantially Equivalent on May 17, 2001, 119 days after the submission was received.
What is the product code of K010177?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.