Lin-Zhi International, Inc. · Class II · Cleared May 8, 2012
| K-number | K120761 |
| Device name | LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS |
| Applicant | Lin-Zhi International, Inc. |
| Product code | DJG |
| Device class | Class II |
| Decision date | May 8, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.3650 |
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