American Dade · Class U · Cleared Sep 18, 1985
| K-number | K853548 |
| Device name | STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS |
| Applicant | American Dade |
| Product code | LCM |
| Device class | Class U |
| Decision date | Sep 18, 1985 |
| Decision | Substantially Equivalent |
| Regulation | — |
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