The following data is part of a premarket notification filed by Roche Professional Diagnostics with the FDA for Elecsys Ca-125 Ii Assay.
| Device ID | K143534 |
| 510k Number | K143534 |
| Device Name: | Elecsys CA-125 II Assay |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | ROCHE PROFESSIONAL DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Linda Mccammack |
| Correspondent | Linda Mccammack ROCHE PROFESSIONAL DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-12 |
| Decision Date | 2015-08-06 |
| Summary: | summary |