Spectral Diagnostics, Inc. · Class II · Cleared Oct 4, 1999
| K-number | K992127 |
| Device name | CARDIOQUANT TROPONIN I TEST |
| Applicant | Spectral Diagnostics, Inc. |
| Product code | MMI |
| Device class | Class II |
| Decision date | Oct 4, 1999 |
| Decision | Substantially Equivalent |
| Regulation | 862.1215 |
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