Hyphen Biomed · Class II · Cleared Sep 7, 2007
| K-number | K071255 |
| Device name | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A |
| Applicant | Hyphen Biomed |
| Product code | LCO |
| Device class | Class II |
| Decision date | Sep 7, 2007 |
| Decision | Substantially Equivalent |
| Regulation | 864.7695 |
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