Gen-Probe, Inc. · Class II · Cleared Oct 4, 2006
| K-number | K061509 |
| Device name | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 |
| Applicant | Gen-Probe, Inc. |
| Product code | LSL |
| Device class | Class II |
| Decision date | Oct 4, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 866.3390 |
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