Digene Corp. · Class I · Cleared Sep 25, 2001
| K-number | K010891 |
| Device name | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 |
| Applicant | Digene Corp. |
| Product code | LSK |
| Device class | Class I |
| Decision date | Sep 25, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 866.3120 |
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