510(k) Report

Devices descending from P910007

2 later devices reach Axsym Total Psa & Architect Total Psa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994419Fastpack Psa Immunoassay, Fastpack SystemQualisys Diagnostics, Inc.200002
+1K990234Qualisys Psa ImmunoassayQualisys Diagnostics, Inc.19990—