Helena Laboratories · Class I · Cleared Nov 10, 1994
| K-number | K935162 |
| Device name | REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT |
| Applicant | Helena Laboratories |
| Product code | JHO |
| Device class | Class I |
| Decision date | Nov 10, 1994 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov