Hybritech, Inc. · Class II · Cleared Oct 8, 1986
| K-number | K863345 |
| Device name | TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY |
| Applicant | Hybritech, Inc. |
| Product code | DBF |
| Device class | Class II |
| Decision date | Oct 8, 1986 |
| Decision | Substantially Equivalent |
| Regulation | 866.5340 |
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