Cambridge Diagnostics Ireland, Ltd. · Class II · Cleared Apr 9, 1998
| K-number | K970761 |
| Device name | LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) |
| Applicant | Cambridge Diagnostics Ireland, Ltd. |
| Product code | LSR |
| Device class | Class II |
| Decision date | Apr 9, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 866.3830 |
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