Phadia US, Inc. · Class II · Cleared Feb 15, 2012
| K-number | DEN120001 |
| Device name | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE |
| Applicant | Phadia US, Inc. |
| Product code | OYL |
| Device class | Class II |
| Decision date | Feb 15, 2012 |
| Decision | Not Substantially Equivalent |
| Regulation | 866.5760 |
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