Psychemedics Microplate EIA for Fentanyl in Hair
FDA 510(k) K182103 · Psychemedics Corporation
510(k) numberK182103
Submission
- Device name
- Psychemedics Microplate EIA for Fentanyl in Hair
- Applicant
- Psychemedics Corporation
Culver City, CA, US - Received
- August 3, 2018
- Decision date
- April 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | Medtox Diagnostics, Inc. | 01/29/2026SE |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 01/23/2026SE |
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | Immunalysis Corporation | 09/11/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | Healgen Scientific,, LLC | 08/15/2025SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
More from Shanghai Accurature Diagnostics Co., Ltd.
| 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 |
| 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 |
| K111928 | Psychemedics Phencyclidine EiaLCM · Traditional | 05/01/2012SE |
Questions and answers
When was Psychemedics Microplate EIA for Fentanyl in Hair cleared by the FDA?
Psychemedics Microplate EIA for Fentanyl in Hair (K182103) received a 510(k) decision of Substantially Equivalent on April 18, 2019, 258 days after the submission was received.
What is the product code of K182103?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.