Bayer Diagnostics Corp. · Class II · Cleared Nov 14, 2003
| K-number | K033007 |
| Device name | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM |
| Applicant | Bayer Diagnostics Corp. |
| Product code | KXT |
| Device class | Class II |
| Decision date | Nov 14, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 862.3320 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov