The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Bayer Special Chemistry Calibrators.
| Device ID | K033380 |
| 510k Number | K033380 |
| Device Name: | BAYER SPECIAL CHEMISTRY CALIBRATORS |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Andres Holle |
| Correspondent | Andres Holle BAYER DIAGNOSTICS CORP. 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 | 2003-10-22 |
| Decision Date | 2003-12-16 |
| Summary: | summary |