510(k) Report

Devices descending from P980018

2 later devices reach Dako Herceptest through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023335QCS HER2 Immunocontrols (Product NO. C010)Qc Sciences, LLC20031—
+2K220163Her-2, ER, PR IHControlsBoston Cell Standards, Inc.20220—