| K-number | K954831 |
| Device name | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY |
| Applicant | Orgentec |
| Product code | LKO |
| Device class | Class II |
| Decision date | May 8, 1996 |
| Decision | Substantially Equivalent |
| Regulation | 866.5100 |
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