Helena Laboratories · Class I · Cleared May 1, 1998
| K-number | K980650 |
| Device name | REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL |
| Applicant | Helena Laboratories |
| Product code | JHO |
| Device class | Class I |
| Decision date | May 1, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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