Baxter Healthcare Corp · Class II · Cleared Aug 3, 1989
| K-number | K893577 |
| Device name | STATUS HCG FLUOROMETRIC ENZYME |
| Applicant | Baxter Healthcare Corp |
| Product code | DHA |
| Device class | Class II |
| Decision date | Aug 3, 1989 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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