Helena Laboratories · Class II · Cleared Jan 9, 1981
| K-number | K803108 |
| Device name | HELENA HBA2 QUIK COLUMN METHOD |
| Applicant | Helena Laboratories |
| Product code | JPD |
| Device class | Class II |
| Decision date | Jan 9, 1981 |
| Decision | Substantially Equivalent |
| Regulation | 864.7400 |
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