The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia 1650 Chemistry System.
| Device ID | K990346 |
| 510k Number | K990346 |
| Device Name: | BAYER ADVIA 1650 CHEMISTRY SYSTEM |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca, Jr. |
| Correspondent | Gabriel J Muraca, Jr. BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-04 |
| Decision Date | 1999-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414482330 | K990346 | 000 |
| 00630414595467 | K990346 | 000 |
| 00630414534794 | K990346 | 000 |
| 00630414482262 | K990346 | 000 |
| 00630414478654 | K990346 | 000 |
| 00630414210087 | K990346 | 000 |
| 00630414210070 | K990346 | 000 |
| 00630414210056 | K990346 | 000 |
| 00630414210001 | K990346 | 000 |
| 00630414209982 | K990346 | 000 |
| 00630414595474 | K990346 | 000 |
| 00630414595498 | K990346 | 000 |
| 00630414482323 | K990346 | 000 |
| 00630414482316 | K990346 | 000 |
| 00630414482309 | K990346 | 000 |
| 00630414210247 | K990346 | 000 |
| 00630414210230 | K990346 | 000 |
| 00630414601182 | K990346 | 000 |
| 00630414601175 | K990346 | 000 |
| 00630414601052 | K990346 | 000 |
| 00630414595504 | K990346 | 000 |
| 00630414168258 | K990346 | 000 |