The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Ov Monitor Assay.
| Device ID | K031297 |
| 510k Number | K031297 |
| Device Name: | ACCESS OV MONITOR ASSAY |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Lynn Weist |
| Correspondent | Lynn Weist BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-24 |
| Decision Date | 2003-05-02 |
| Summary: | summary |