510(k) Report

Devices descending from K964351

2 later devices reach Elecsys Psa Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982949Elecsys Psa, Model 2010Boehringer Mannheim Corp.19980—
+1K974189Elecsys Psa (on Elecsys 1010)Boehringer Mannheim Corp.19980—