Genetic Testing Institute · Class II · Cleared Jan 20, 2006
| K-number | K053559 |
| Device name | PF4 ENHANCED SOLID PHASE ELISA |
| Applicant | Genetic Testing Institute |
| Product code | LCO |
| Device class | Class II |
| Decision date | Jan 20, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 864.7695 |
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