The following data is part of a premarket notification filed by Digene Corp. with the FDA for Hybrid Capture Ii Ct-id Test.
| Device ID | K990023 |
| 510k Number | K990023 |
| Device Name: | HYBRID CAPTURE II CT-ID TEST |
| Classification | Dna-reagents, Chlamydia |
| Applicant | DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville, MD 20705 |
| Contact | Mark Del Vecchio |
| Correspondent | Mark Del Vecchio DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville, MD 20705 |
| Product Code | LSK |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-05 |
| Decision Date | 1999-10-25 |
| Summary: | summary |