| K-number | K944243 |
| Device name | CARDIOCHEX |
| Applicant | Cala Diagnostics |
| Product code | JJT |
| Device class | Class I |
| Decision date | Oct 27, 1994 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
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