Bayer Diagnostics Corp. · Class II · Cleared Dec 5, 2000
| K-number | K003291 |
| Device name | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY |
| Applicant | Bayer Diagnostics Corp. |
| Product code | JZO |
| Device class | Class II |
| Decision date | Dec 5, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 866.5870 |
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