510(k) Report

Devices descending from K972068

3 later devices reach Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121463Immunocap Allergen K82Thermo Fisher Scientific201301
+1K030590Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Hitachi Chemical Diagnostics, Inc.20031—
+2K051677Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc.200601