Psychemedics Cocaine Eia
FDA 510(k) K111925 · Psychemedics Corp.
510(k) numberK111925
Submission
- Device name
- Psychemedics Cocaine 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
- JXO – Enzyme Immunoassay, Cocaine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairJXO · Traditional | Psychemedics Corporation | 06/25/2021SE |
| K923314 | Automates Coma Plus Cocaine Metabolite AssayJXO · Traditional | Serex, Inc. | 08/24/1992SE |
| K921140 | STC Diagnostics AUTO0LYTE Cocaine Metabolite EiaJXO · Traditional | Solarcare Technologies Corp,Inc. | 08/20/1992SE |
| K915785 | STC Diagnostics Benzoylecgonine EiaJXO · Traditional | Solarcare Technologies Corp,Inc. | 03/11/1992SE |
| K913737 | Il Test(Tm) CocaineJXO · Traditional | Instrumentation Laboratory CO | 12/03/1991SE |
More from Instrumentation Laboratory CO
| 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 |
| K111929 | Psychemedics Cannabinoids EiaLDJ · Traditional | 05/01/2012SE |
Questions and answers
When was Psychemedics Cocaine Eia cleared by the FDA?
Psychemedics Cocaine Eia (K111925) 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 K111925?
The FDA product code is JXO – Enzyme Immunoassay, Cocaine, a Class II (moderate risk) device regulated under 21 CFR 862.3250.