510(k) Report

Devices descending from K120009

2 later devices reach Testosterone Test System; Calibrator; and Quality Control Material (Assayed… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153577FREND Testosterone Test SystemNanoentek USA, Inc.20160—
+1K152155ARCHITECT 2nd Generation TestosteroneAbbott Laboratories20150—