The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Bayer Advia Chemistry Special Chemistry Control.
| Device ID | K031644 |
| 510k Number | K031644 |
| Device Name: | BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Andres Holle |
| Correspondent | Andres Holle BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-27 |
| Decision Date | 2003-06-25 |
| Summary: | summary |