510(k) Report

Devices descending from K091849

4 later devices reach Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…Immunodiagnostic Systems, Ltd.20150—
+1K140554Ids-Isys 25-Hydroxy Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS Control SetImmunodiagnostic Systems, Ltd.20141—
+1K121608Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack, Vitamin D Total…Ortho-Clinical Diagnostics, Inc.201301
+2K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetImmunodiagnostic Systems, Ltd.20160—