TDX Methadone Assay
FDA 510(k) K884968 · Abbott Laboratories
510(k) numberK884968
Submission
- Device name
- TDX Methadone Assay
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- November 30, 1988
- Decision date
- December 16, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJR – Enzyme Immunoassay, Methadone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3620
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | Lin-Zhi International, Inc. | 10/04/2019SE |
| K182779 | ARK EDDP AssayDJR · Traditional | Ark Diagnostics, Inc. | 11/21/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | Lin-Zhi International, Inc. | 06/26/2017SE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…DJR · Traditional | W.H.P.M., Inc. | 08/17/2016SE |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJR · Traditional | Assure Tech. Co., Ltd. | 10/05/2015SE |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…DJR · Traditional | Immunalysis Corporation | 07/24/2015SE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | W.H.P.M., Inc. | 06/29/2015SE |
| K131232 | Wondfo Methadone Urine Test (MTD 200), Wondofo Morphine Urine Test (Mop 100)DJR · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/31/2013SE |
| K092272 | Randox Methadone AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/18/2010SE |
| K092258 | Randox Metabolite (Eddp) AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/09/2010SE |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252424 | Anti-HCV NextMZO · Traditional | 04/28/2026SE |
| K243500 | ARCHITECT iGentamicinLCD · Special | 07/09/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | 06/20/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | 02/20/2025SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | 08/30/2024SE |
| K232669 | TbiQAT · Special | 09/29/2023SE |
| K222850 | HAVAb IgG IILOL · Traditional | 08/10/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | 08/04/2023SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | 07/14/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | 06/05/2023SE |
Questions and answers
When was TDX Methadone Assay cleared by the FDA?
TDX Methadone Assay (K884968) received a 510(k) decision of Substantially Equivalent on December 16, 1988, 16 days after the submission was received.
What is the product code of K884968?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.