Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020
FDA 510(k) K023252 · Icn Biomedicals, Inc.
510(k) numberK023252
Submission
- Device name
- Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020
- Applicant
- Icn Biomedicals, Inc.
Burlingame, CA, US - Received
- September 30, 2002
- Decision date
- November 22, 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 |
|---|---|---|
| K030211 | Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016DKX · Traditional | 06/13/2003SE |
| K926106 | Immuchem Phe-Mw EaJNB · Traditional | 02/08/1995SE |
| K922944 | Immuchem Lh-Mw ElisaCEP · Traditional | 02/02/1993SE |
| K922715 | Immuchem Prl-Mw ElisaCFT · Traditional | 10/05/1992SE |
| K922376 | Icn Biomedicals Immuchem(Tm) Fsh-Mw Elisa KitCGJ · Traditional | 10/05/1992SE |
| K920442 | Immuchem Tsh-Mw ElisaJLW · Traditional | 03/18/1992SE |
| K913963 | Immuchem Neonatal Tsh-Mp ElisaJLW · Traditional | 12/13/1991SE |
| K902445 | Lympho Sep(Tm)JCF · Traditional | 08/22/1990SE |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) Neo. RiaJLX · Traditional | 02/23/1989SE |
| K881005 | Immuchem Human Chorionic Gonadotropin Hormone HCGJHI · Traditional | 05/27/1988SE |
Questions and answers
When was Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020 cleared by the FDA?
Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020 (K023252) received a 510(k) decision of Substantially Equivalent on November 22, 2002, 53 days after the submission was received.
What is the product code of K023252?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.