DJR — Enzyme Immunoassay, Methadone Class II
FDA product code DJR covers "Enzyme Immunoassay, Methadone", a Class II medical device regulated under 21 CFR 862.3620. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DJR
- Device Class
- Class II
- Regulation Number
- 862.3620
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K192433 | lin-zhi international | LZI Methadone II Enzyme Immunoassay | October 4, 2019 |
| K182779 | ark diagnostics | ARK EDDP Assay | November 21, 2018 |
| K170416 | lin-zhi international | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 3 | June 26, 2017 |
| K160793 | w.h.p.m | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign D | August 17, 2016 |
| K152025 | assure tech. co | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | October 5, 2015 |
| K151395 | immunalysis corporation | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calib | July 24, 2015 |
| K151441 | w.h.p.m | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | June 29, 2015 |
| K131232 | guangzhou wondfo biotech co | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) | May 31, 2013 |
| K092272 | randox laboratories | RANDOX METHADONE ASSAY | November 18, 2010 |
| K092258 | randox laboratories | RANDOX METABOLITE (EDDP) ASSAY | November 9, 2010 |
| K092048 | biosite incorporated | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP | April 19, 2010 |
| K081378 | thermo fisher scientific | DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS | January 14, 2009 |
| K062637 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERI | November 22, 2006 |
| K060791 | biosite incorporated | TRIAGE TOX DRUG SCREEN, MODEL 94400 | June 22, 2006 |
| K052197 | w.h.p.m | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST | June 9, 2006 |
| K051058 | lin-zhi international | METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | March 29, 2006 |
| K040570 | randox laboratories | RANDOX METHADONE ASSAY | May 10, 2004 |
| K031797 | lin-zhi international | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. | October 10, 2003 |
| K023617 | microgenics | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY | August 27, 2003 |
| K023856 | sun biomedical laboratories | VISUALINE METHADONE DIPSTRIPTEST | August 25, 2003 |