Digene Corp.
Medical device manufacturer in Gaithersburg, MD.
9510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K010891 | Modification to Hybrid Capture II Ct/Gc Test, Model 03M90-01LSK · Traditional | 09/25/2001SE |
| K010893 | Modification to Hybrid Capture 2 Gc-Id DNA Test, Model 03M92-01LSL · Traditional | 09/24/2001SE |
| K010892 | Modification Hybrid Capture II Ct-Id DNA Test, Model 03M91-01LSK · Traditional | 09/24/2001SE |
| K981567 | Hybrid Capture II Ct/Gc TestLSL · Traditional | 02/29/2000SE |
| K981485 | Hybrid Capture II Gc-IdLSL · Traditional | 11/29/1999SE |
| K990023 | Hybrid Capture II Ct-Id TestLSK · Traditional | 10/25/1999SE |
| K974901 | Hybrid Capture System CMV DNA AssayLJO · Traditional | 09/29/1998SE |
| K980120 | Digene DML 2000 Microplate LuminometerJJQ · Traditional | 02/06/1998SE |
| K971586 | Digene Cervical BrushHHT · Traditional | 09/19/1997SE |