K192433 is an FDA 510(k) clearance for the LZI Methadone II Enzyme Immunoassay. This device is classified as a Enzyme Immunoassay, Methadone (Class II - Special Controls, product code DJR).
Submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 4, 2019, 29 days after receiving the submission on September 5, 2019.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3620.
| 510(k) Number | K192433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2019 |
| Decision Date | October 04, 2019 |
| Days to Decision | 29 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 |