The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Bayer Advia 1650 Special Chemistry Calibrator.
| Device ID | K030804 |
| 510k Number | K030804 |
| Device Name: | BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Andres Holle |
| Correspondent | Andres Holle BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-13 |
| Decision Date | 2003-04-10 |
| Summary: | summary |