The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Bayer Advia Centaur Ca 19-9 Assay.
| Device ID | K031393 |
| 510k Number | K031393 |
| Device Name: | BAYER ADVIA CENTAUR CA 19-9 ASSAY |
| Classification | System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | NIG |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-02 |
| Decision Date | 2003-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598192 | K031393 | 000 |
| 00630414447926 | K031393 | 000 |
| 00630414574028 | K031393 | 000 |
| 00630414574257 | K031393 | 000 |
| 00630414577128 | K031393 | 000 |
| 00630414577135 | K031393 | 000 |
| 00630414598161 | K031393 | 000 |
| 00630414598178 | K031393 | 000 |
| 00630414598185 | K031393 | 000 |
| 00630414293516 | K031393 | 000 |