Psychemedics Cannabinoids Eia
FDA 510(k) K111929 · Psychemedics Corp.
510(k) numberK111929
Submission
- Device name
- Psychemedics Cannabinoids Eia
- Applicant
- Psychemedics Corp.
Culver City, CA, US - Received
- July 6, 2011
- Decision date
- May 1, 2012
- 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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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairLCM · Traditional | 04/18/2022SE |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairLAF · Traditional | 12/15/2021SE |
| K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics…DJG · Traditional | 07/27/2021SE |
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairJXO · Traditional | 06/25/2021SE |
| K192517 | Psychemedics Microplate EIA for Cotinine in HairMKU · Traditional | 04/22/2020SE |
| K182103 | Psychemedics Microplate EIA for Fentanyl in HairDJG · Traditional | 04/18/2019SE |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in HairJXM · Traditional | 09/15/2017SE |
| K130811 | Psychemedics Microplate Eia for AmphetamineDKZ · Traditional | 05/02/2013SE |
| K123799 | Psychemedics Microplate Eia for Oxycodone in HairDJG · Traditional | 02/08/2013SE |
| K111928 | Psychemedics Phencyclidine EiaLCM · Traditional | 05/01/2012SE |
Questions and answers
When was Psychemedics Cannabinoids Eia cleared by the FDA?
Psychemedics Cannabinoids Eia (K111929) received a 510(k) decision of Substantially Equivalent on May 1, 2012, 300 days after the submission was received.
What is the product code of K111929?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.