Helena Laboratories · Class I · Cleared Aug 15, 2002
| K-number | K022333 |
| Device name | SPIFE LIPPOROTEIN-12, MODEL 3344 |
| Applicant | Helena Laboratories |
| Product code | JHO |
| Device class | Class I |
| Decision date | Aug 15, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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