American Dade · Class II · Cleared Sep 12, 1984
| K-number | K843237 |
| Device name | STRATUS QUINIDINE FLUOROMETRIC ENZYME |
| Applicant | American Dade |
| Product code | LBZ |
| Device class | Class II |
| Decision date | Sep 12, 1984 |
| Decision | Substantially Equivalent |
| Regulation | 862.3320 |
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