Psychemedics Microplate EIA for Benzodiazepines in Hair
FDA 510(k) K163590 · Psychemedics Corporation
510(k) numberK163590
Submission
- Device name
- Psychemedics Microplate EIA for Benzodiazepines in Hair
- Applicant
- Psychemedics Corporation
Culver City, CA, US - Received
- December 20, 2016
- Decision date
- September 15, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JXM – Enzyme Immunoassay, Benzodiazepine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3170
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JXM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent KitJXM · Special | Microgenics Corporation | 12/11/2024SE |
| K221765 | ONLINE DAT Benzodiazepines IIJXM · Traditional | Roche Diagnostics | 12/23/2022SE |
| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | Microgenics Corporation | 12/09/2019SE |
| K173963 | DRI Benzodiazepine AssayJXM · Traditional | Microgenics Corporation | 02/21/2018SE |
| K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 08/02/2017SE |
| K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 05/23/2016SE |
| K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsJXM · Traditional | Immunalysis Corporation | 01/05/2016SE |
| K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 08/13/2015SE |
| K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 05/13/2015SE |
| K123080 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsJXM · Traditional | Chemtron Biotech, Inc. | 11/29/2012SE |
More from Chemtron Biotech, Inc.
| 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 |
| 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 |
| K111928 | Psychemedics Phencyclidine EiaLCM · Traditional | 05/01/2012SE |
Questions and answers
When was Psychemedics Microplate EIA for Benzodiazepines in Hair cleared by the FDA?
Psychemedics Microplate EIA for Benzodiazepines in Hair (K163590) received a 510(k) decision of Substantially Equivalent on September 15, 2017, 269 days after the submission was received.
What is the product code of K163590?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.