The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Ca 125 Ii Assay For The Bayer Advia Integrated Module System.
| Device ID | K022329 |
| 510k Number | K022329 |
| Device Name: | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-18 |
| Decision Date | 2002-11-27 |
| Summary: | summary |