Lin-Zhi International, Inc. · Class II · Cleared Dec 19, 2003
| K-number | K033094 |
| Device name | ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) |
| Applicant | Lin-Zhi International, Inc. |
| Product code | DKZ |
| Device class | Class II |
| Decision date | Dec 19, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 862.3100 |
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