Helena Laboratories · Class I · Cleared Dec 23, 1996
| K-number | K964471 |
| Device name | REP FLUR CHOLESTEROL-60 KIT |
| Applicant | Helena Laboratories |
| Product code | JHO |
| Device class | Class I |
| Decision date | Dec 23, 1996 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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