The following data is part of a premarket notification filed by Digene Corp. with the FDA for Modification To Hybrid Capture Ii Ct/gc Test, Model 03m90-01.
| Device ID | K010891 |
| 510k Number | K010891 |
| Device Name: | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 |
| Classification | Dna-reagents, Chlamydia |
| Applicant | DIGENE CORP. 1201 CLOPPER RD. Gaithersburg, MD 20878 |
| Contact | Mark A Del Vecchio |
| Correspondent | Mark A Del Vecchio DIGENE CORP. 1201 CLOPPER RD. Gaithersburg, MD 20878 |
| Product Code | LSK |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-26 |
| Decision Date | 2001-09-25 |