American Dade · Class II · Cleared May 17, 1983
| K-number | K831177 |
| Device name | STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM- |
| Applicant | American Dade |
| Product code | KXT |
| Device class | Class II |
| Decision date | May 17, 1983 |
| Decision | Substantially Equivalent |
| Regulation | 862.3320 |
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