Nichols Institute Diagnostics · Class II · Cleared Dec 17, 2004
| K-number | K042676 |
| Device name | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY |
| Applicant | Nichols Institute Diagnostics |
| Product code | DHA |
| Device class | Class II |
| Decision date | Dec 17, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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