Peace of Mind Multiple Drugs of Abuse Test
FDA 510(k) K001126 · Alatex Scientific, Inc.
510(k) numberK001126
Submission
- Device name
- Peace of Mind Multiple Drugs of Abuse Test
- Applicant
- Alatex Scientific, Inc.
Mountian View, CA, US - Received
- April 7, 2000
- Decision date
- August 7, 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
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| 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 |
Questions and answers
When was Peace of Mind Multiple Drugs of Abuse Test cleared by the FDA?
Peace of Mind Multiple Drugs of Abuse Test (K001126) received a 510(k) decision of Substantially Equivalent on August 7, 2000, 122 days after the submission was received.
What is the product code of K001126?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.