The following data is part of a premarket notification filed by Digene Corp. with the FDA for Hybrid Capture Ii Ct/gc Test.
| Device ID | K981567 |
| 510k Number | K981567 |
| Device Name: | HYBRID CAPTURE II CT/GC TEST |
| Classification | Dna-reagents, Neisseria |
| Applicant | DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville, MD 20705 |
| Contact | Mark A Del Vecchio |
| Correspondent | Mark A Del Vecchio DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville, MD 20705 |
| Product Code | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-01 |
| Decision Date | 2000-02-29 |
| Summary: | summary |