The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Immuno 1 System Ferritin Assay.
| Device ID | K982714 |
| 510k Number | K982714 |
| Device Name: | BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY |
| Classification | Ferritin, Antigen, Antiserum, Control |
| 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 | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-04 |
| Decision Date | 1998-10-22 |
| Summary: | summary |