Methadone Enzyme Immunoassay
FDA 510(k) K023317 · Lin-Zhi International, Inc.
510(k) numberK023317
Submission
- Device name
- Methadone Enzyme Immunoassay
- Applicant
- Lin-Zhi International, Inc.
San Jose, CA, US - Received
- October 3, 2002
- Decision date
- December 12, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | 01/16/2026SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | 06/18/2025SE |
| K202007 | LZI Oxycodone III Enzyme ImmunoassayDJG · Traditional | 09/17/2020SE |
| K201938 | LZI Fentanyl II Enzyme ImmunoassayDJG · Traditional | 08/07/2020SE |
| K201223 | LZI Tramadol Enzyme ImmunoassayDJG · Traditional | 06/04/2020SE |
| K192299 | LZI Cotinine II Enzyme ImmunoassayMKU · Traditional | 11/21/2019SE |
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | 10/04/2019SE |
| K181159 | LZI Fentanyl Enzyme ImmunoassayDJG · Traditional | 12/03/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | 06/26/2017SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | 05/28/2015SE |
Questions and answers
When was Methadone Enzyme Immunoassay cleared by the FDA?
Methadone Enzyme Immunoassay (K023317) received a 510(k) decision of Substantially Equivalent on December 12, 2002, 70 days after the submission was received.
What is the product code of K023317?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.