Lin-Zhi International, Inc. · Class II · Cleared Oct 10, 2003
| K-number | K031797 |
| Device name | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) |
| Applicant | Lin-Zhi International, Inc. |
| Product code | DJR |
| Device class | Class II |
| Decision date | Oct 10, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 862.3620 |
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