The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Additional Assays For The Bayer Advia 1650 Chemistry System.
| Device ID | K991576 |
| 510k Number | K991576 |
| Device Name: | ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | CIX |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CFO |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGS |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CIC |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CJK |
| Subsequent Product Code | JFY |
| Subsequent Product Code | JIY |
| Subsequent Product Code | KHM |
| Subsequent Product Code | KNK |
| Subsequent Product Code | LBS |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-06 |
| Decision Date | 1999-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596501 | K991576 | 000 |
| 00630414501789 | K991576 | 000 |
| 00630414209746 | K991576 | 000 |
| 00630414209586 | K991576 | 000 |
| 00630414596402 | K991576 | 000 |
| 00630414596334 | K991576 | 000 |
| 00630414596303 | K991576 | 000 |
| 00630414561974 | K991576 | 000 |
| 00630414553191 | K991576 | 000 |
| 00630414526737 | K991576 | 000 |
| 00630414526713 | K991576 | 000 |
| 00630414517698 | K991576 | 000 |
| 00630414517650 | K991576 | 000 |
| 00630414513157 | K991576 | 000 |
| 00630414508429 | K991576 | 000 |
| 00630414508399 | K991576 | 000 |
| 00630414508313 | K991576 | 000 |
| 00630414508320 | K991576 | 000 |
| 00630414508337 | K991576 | 000 |
| 00630414508351 | K991576 | 000 |
| 00630414596471 | K991576 | 000 |
| 00630414596426 | K991576 | 000 |
| 00630414596389 | K991576 | 000 |
| 00630414595672 | K991576 | 000 |
| 00630414555904 | K991576 | 000 |
| 00630414553214 | K991576 | 000 |
| 00630414553184 | K991576 | 000 |
| 00630414553153 | K991576 | 000 |
| 00630414538716 | K991576 | 000 |
| 00630414526706 | K991576 | 000 |
| 00630414517513 | K991576 | 000 |
| 00630414517506 | K991576 | 000 |
| 00630414517490 | K991576 | 000 |
| 00630414517452 | K991576 | 000 |
| 00630414510163 | K991576 | 000 |
| 00630414508405 | K991576 | 000 |
| 00630414209845 | K991576 | 000 |