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 |