Advantage THC Test
FDA 510(k) K001567 · Advantage Diagnostics Corp.
510(k) numberK001567
Submission
- Device name
- Advantage THC Test
- Applicant
- Advantage Diagnostics Corp.
Redwood City, CA, US - Received
- May 19, 2000
- Decision date
- June 19, 2000
- 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
Other 510(k)s with product code LDJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…LDJ · Traditional | Co-Innovation Biotech Co., Ltd. | 01/17/2024SE |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit…LDJ · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 01/10/2024SE |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTLDJ · Traditional | Healgen Scientific,, LLC | 03/17/2023SE |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 10/11/2019SE |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestLDJ · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 03/18/2016SE |
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…LDJ · Traditional | Nantong Egens Biotech Co., Ltd. | 11/02/2015SE |
| 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 |
|---|---|---|
| K023712 | Advantage Multiple Drugs of Abuse TestDKZ · Traditional | 01/31/2003SE |
| K013778 | Peace of Mind Home Drug TestMVO · Traditional | 02/07/2002SE |
| K011962 | Advantage Marijuana (THC) and Cocaine Home Drug TestDIO · Traditional | 08/09/2001SE |
| K010921 | Advantage Marijuana (THC) Home Drug TestLDJ · Traditional | 06/25/2001SE |
| K003708 | Advantage Thc/Cocaine TestDIO · Traditional | 01/22/2001SE |
| 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 THC Test cleared by the FDA?
Advantage THC Test (K001567) received a 510(k) decision of Substantially Equivalent on June 19, 2000, 31 days after the submission was received.
What is the product code of K001567?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.