The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Ca 15-3 Assay For The Advia Centaur System.
| Device ID | K012357 |
| 510k Number | K012357 |
| Device Name: | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM |
| Classification | System, Test, Immunological, Antigen, Tumor |
| 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 | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-25 |
| Decision Date | 2002-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598154 | K012357 | 000 |
| 00630414598147 | K012357 | 000 |
| 00630414598130 | K012357 | 000 |
| 00630414598123 | K012357 | 000 |
| 00630414461359 | K012357 | 000 |
| 00630414461328 | K012357 | 000 |
| 00630414461311 | K012357 | 000 |
| 00630414461281 | K012357 | 000 |
| 00630414294063 | K012357 | 000 |