510(k) Report

Devices descending from K991048

2 later devices reach Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113841Immunocap Allergen Components BundlePhadia US, Inc.20121—
+2K151029Phadia PrimePhadia AB201601