Dade Intl., Inc. · Class II · Cleared Jul 13, 1995
| K-number | K951890 |
| Device name | STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS |
| Applicant | Dade Intl., Inc. |
| Product code | MMI |
| Device class | Class II |
| Decision date | Jul 13, 1995 |
| 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