Phadia AB · Class II · Cleared Jul 28, 2016
| K-number | K161899 |
| Device name | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls |
| Applicant | Phadia AB |
| Product code | DGC |
| Device class | Class II |
| Decision date | Jul 28, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 866.5510 |
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