Psychemedics Ria Methamphetamine and Mdma Assay
FDA 510(k) K011185 · Psychemedics Corp.
510(k) numberK011185
Submission
- Device name
- Psychemedics Ria Methamphetamine and Mdma Assay
- Applicant
- Psychemedics Corp.
Culver City, CA, US - Received
- April 18, 2001
- Decision date
- January 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJC – Thin Layer Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253705 | Healgen® Accurate Oral Fluid Drug TestDJC · Traditional | Healgen Scientific,, LLC | 03/16/2026SE |
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube)DJC · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 03/18/2025SE |
| K180878 | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test…DJC · Traditional | Shanghai Venture Bio-Tech Co., Ltd. | 12/17/2018SE |
| K181305 | OralTox Oral fluid Drug TestDJC · Traditional | Premier Biotech, Inc. | 09/20/2018SE |
| K171403 | OralTox Oral Fluid Drug TestDJC · Traditional | Premier Biotech, Inc. | 02/02/2018SE |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJC · Traditional | Assure Tech. (Hangzhou) Co, Ltd. | 07/06/2016SE |
| K132630 | Wondfo Oxazepam Urine Test (Bzo 200) and Wondfo Methamphetamine Urine Test (Met 300)DJC · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 09/27/2013SE |
| K080347 | Uniscan -Doa SystemDJC · Traditional | Taiwan Unison Biotech, Inc. | 10/09/2008SE |
| K060355 | Acro Biotech LLC Rapid Mdma Urine Test, Catalog MDMA0010000DJC · Traditional | Acro Biotech, LLC | 08/07/2006SE |
| K060896 | Modification to Ontrak Testcup II and Onsite CupkitDJC · Traditional | Varian, Inc. | 06/09/2006SE |
More from Varian, 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 |
| 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 Ria Methamphetamine and Mdma Assay cleared by the FDA?
Psychemedics Ria Methamphetamine and Mdma Assay (K011185) received a 510(k) decision of Substantially Equivalent on January 24, 2002, 281 days after the submission was received.
What is the product code of K011185?
The FDA product code is DJC – Thin Layer Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.