Lin-Zhi International, Inc. · Class II · Cleared Jul 6, 2010
| K-number | K101195 |
| Device name | 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS |
| Applicant | Lin-Zhi International, Inc. |
| Product code | DJG |
| Device class | Class II |
| Decision date | Jul 6, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 862.3650 |
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