The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Ca 125 Assay For The Advia Centaur System.
| Device ID | K020828 |
| 510k Number | K020828 |
| Device Name: | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER 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 | 2002-03-14 |
| Decision Date | 2002-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598116 | K020828 | 000 |
| 00630414598109 | K020828 | 000 |
| 00630414598093 | K020828 | 000 |
| 00630414598086 | K020828 | 000 |
| 00630414461335 | K020828 | 000 |
| 00630414461304 | K020828 | 000 |
| 00630414461298 | K020828 | 000 |
| 00630414461274 | K020828 | 000 |
| 00630414294278 | K020828 | 000 |