Phadia US, Inc. · Class II · Cleared Aug 28, 2013
| K-number | K122197 |
| Device name | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES |
| Applicant | Phadia US, Inc. |
| Product code | DHB |
| Device class | Class II |
| Decision date | Aug 28, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 866.5750 |
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