K251634 is an FDA 510(k) clearance for the LZI Fentanyl III Enzyme Immunoassay. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on June 18, 2025, 20 days after receiving the submission on May 29, 2025.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K251634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2025 |
| Decision Date | June 18, 2025 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |