K031297 is an FDA 510(k) clearance for the ACCESS OV MONITOR ASSAY. This device is classified as a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II - Special Controls, product code LTK).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on May 2, 2003, 8 days after receiving the submission on April 24, 2003.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K031297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2003 |
| Decision Date | May 02, 2003 |
| Days to Decision | 8 days |
| Submission Type | Special |
| 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 |