Pointe Scientific, Inc., · Class I · Cleared Sep 24, 1981
| K-number | K812574 |
| Device name | HDL CHOLESTEROL REAGENT |
| Applicant | Pointe Scientific, Inc., |
| Product code | LBR |
| Device class | Class I |
| Decision date | Sep 24, 1981 |
| 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