Advantage Multiple Drugs of Abuse Test
FDA 510(k) K023712 · Advantage Diagnostics Corp.
510(k) numberK023712
Submission
- Device name
- Advantage Multiple Drugs of Abuse Test
- Applicant
- Advantage Diagnostics Corp.
Sunnyvale, CA, US - Received
- November 4, 2002
- Decision date
- January 31, 2003
- 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 |
|---|---|---|
| K013778 | Peace of Mind Home Drug TestMVO · Traditional | 02/07/2002SE |
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| K010921 | Advantage Marijuana (THC) Home Drug TestLDJ · Traditional | 06/25/2001SE |
| K003708 | Advantage Thc/Cocaine TestDIO · Traditional | 01/22/2001SE |
| K001567 | Advantage THC TestLDJ · Traditional | 06/19/2000SE |
| K994227 | Advantage HCG Test (Urine/Serum)JHI · Traditional | 02/03/2000SE |
| K991883 | Redi-Test OpiatesDJG · Traditional | 09/15/1999SE |
| K903416 | Cannula, SurgicalGEA · Traditional | 11/23/1990SE |
| K881369 | Advance Diagnostics Disposable EyecupLXQ · Traditional | 05/13/1988SE |
Questions and answers
When was Advantage Multiple Drugs of Abuse Test cleared by the FDA?
Advantage Multiple Drugs of Abuse Test (K023712) received a 510(k) decision of Substantially Equivalent on January 31, 2003, 88 days after the submission was received.
What is the product code of K023712?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.