510(k) Report

Devices descending from K030590

1 later device reach Cla Allergen-Specific Ige Assay-Latex Allergen (K82) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051677Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc.200601