Phadia AB · Class II · Cleared Mar 2, 2018
| K-number | K173704 |
| Device name | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip |
| Applicant | Phadia AB |
| Product code | OYL |
| Device class | Class II |
| Decision date | Mar 2, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 866.5760 |
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