K031797 is an FDA 510(k) clearance for the METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT). This device is classified as a Enzyme Immunoassay, Methadone (Class II - Special Controls, product code DJR).
Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on October 10, 2003, 122 days after receiving the submission on June 10, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3620.
| 510(k) Number | K031797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2003 |
| Decision Date | October 10, 2003 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJR — Enzyme Immunoassay, Methadone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3620 |