American Dade · Class II · Cleared Feb 11, 1986
| K-number | K860141 |
| Device name | STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. |
| Applicant | American Dade |
| Product code | LAR |
| Device class | Class II |
| Decision date | Feb 11, 1986 |
| Decision | Substantially Equivalent |
| Regulation | 862.3320 |
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