The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Ca 125 Ii Assay.
| Device ID | K080561 |
| 510k Number | K080561 |
| Device Name: | VIDAS CA 125 II ASSAY |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Sandra L Perreand |
| Correspondent | Sandra L Perreand BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-28 |
| Decision Date | 2009-04-10 |
| Summary: | summary |