| K-number | K872728 |
| Device name | BINAX IRMA TOTAL BETA-HCG TEST KIT |
| Applicant | Binax, Inc. |
| Product code | JHI |
| Device class | Class II |
| Decision date | Aug 5, 1987 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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