| K-number | K003412 |
| Device name | ADVIA CENTAUR RUBELLA IGG ASSAY |
| Applicant | Bayer Corp. |
| Product code | LFX |
| Device class | Class II |
| Decision date | Apr 13, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 866.3510 |
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