Helena Laboratories · Class II · Cleared Mar 29, 2002
| K-number | K020467 |
| Device name | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 |
| Applicant | Helena Laboratories |
| Product code | CFE |
| Device class | Class II |
| Decision date | Mar 29, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 862.1445 |
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