Lin-Zhi International, Inc. · Class II · Cleared Nov 3, 2003
| K-number | K032764 |
| Device name | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) |
| Applicant | Lin-Zhi International, Inc. |
| Product code | DIS |
| Device class | Class II |
| Decision date | Nov 3, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 862.3150 |
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