| K-number | K964052 |
| Device name | HEMOCUE HEMOTROL |
| Applicant | Direct Solutions |
| Product code | GGM |
| Device class | Class II |
| Decision date | Nov 6, 1996 |
| Decision | Substantially Equivalent |
| Regulation | 864.8625 |
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