The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Bayer Special Chemistry Controls.
| Device ID | K033379 |
| 510k Number | K033379 |
| Device Name: | BAYER SPECIAL CHEMISTRY CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-22 |
| Decision Date | 2003-12-19 |
| Summary: | summary |