Panels › Immunology › Product code OYL · Class 2
Tryptase Assay System
Regulation 866.5760
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OYL
| Company | 510(k)s | Recalls |
|---|---|---|
| Phadia AB | 1 | 0 |
| Phadia US, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 2, 2018 | K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, I Phadia AB, SE | OYL |
| Feb 15, 2012 | DEN120001 | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE Phadia US, Inc. | OYL |
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