The following data is part of a premarket notification filed by Digene Corp. with the FDA for Digene Dml 2000 Microplate Luminometer.
| Device ID | K980120 |
| 510k Number | K980120 |
| Device Name: | DIGENE DML 2000 MICROPLATE LUMINOMETER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville, MD 20705 |
| Contact | Constance A Finch |
| Correspondent | Constance A Finch DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville, MD 20705 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-13 |
| Decision Date | 1998-02-06 |
| Summary: | summary |