K080561 is an FDA 510(k) clearance for the VIDAS CA 125 II ASSAY. This device is classified as a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II - Special Controls, product code LTK).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on April 10, 2009, 407 days after receiving the submission on February 28, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K080561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2008 |
| Decision Date | April 10, 2009 |
| Days to Decision | 407 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |