Wellcome Diagnostics · Class II · Cleared Jan 31, 1992
| K-number | K915203 |
| Device name | D-DIMER WELLCOTEST (HA10) |
| Applicant | Wellcome Diagnostics |
| Product code | DAP |
| Device class | Class II |
| Decision date | Jan 31, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 864.7320 |
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