Lin-Zhi International, Inc. · Class II · Cleared Jun 13, 2014
| K-number | K141055 |
| Device name | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) |
| Applicant | Lin-Zhi International, Inc. |
| Product code | DJG |
| Device class | Class II |
| Decision date | Jun 13, 2014 |
| Decision | Substantially Equivalent |
| Regulation | 862.3650 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov