The following data is part of a premarket notification filed by Digene Corp. with the FDA for Hybrid Capture System Cmv Dna Assay.
| Device ID | K974901 |
| 510k Number | K974901 |
| Device Name: | HYBRID CAPTURE SYSTEM CMV DNA ASSAY |
| Classification | Antigen, Iha, Cytomegalovirus |
| 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 | LJO |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-31 |
| Decision Date | 1998-09-29 |
| Summary: | summary |