510(k) Report

Devices descending from K831178

3 later devices reach Coat-a-Count NO-Extraction Aldosterone through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…Immunodiagnostic Systems, Ltd.20150—
+1K130321Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration…Diasorin20130—
+1K032188Nichols Advantage Aldosterone AssayNichols Institute Diagnostics20030—