The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Digoxin Assay For The Technicon Ra / Opera Systems.
| Device ID | K980521 |
| 510k Number | K980521 |
| Device Name: | DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS |
| Classification | Enzyme Immunoassay, Digoxin |
| 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 | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-28 |
| Decision Date | 1998-04-02 |
| Summary: | summary |