510(k) Report

Devices descending from K021163

11 later devices reach Octeia 25-Hydroxy Vitamin D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K14235125-Hydroxy Vitamin Ds EIAImmunodiagnostic Systems, Ltd.20150—
+1K12366025-OH Vitamin D ElisaEuroimmun US20132—
+1K12336425OH Vitamin D Total Elisa TestDiasource Immunoassays, S.A.201301
+1K122420Diazyme 25-Hydroxy Vitamin D Eia Kit Diazyme 25-Hydroxy Vitamin D Eia Control Set DiaDiazyme Laboratories20120—
+1K110586Advia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc.201137
+1K102432Diazyme 25-Hydroxy Vitamin D Assay Kit Model DZ688A, Diazyme 25-Hydroxy Vitamin D Assay…Diazyme Laboratories20110—
+2K162298LOCI Total Vitamin D Total Assay, LOCI VITD CALSiemens Healthcare Diagnostics20170—
+2K141114Bioplex (R) 2200 25-OH Vitamin D Kit, Bioplex (R) 2200 25-OH Vitamin D Calibrator Set…Bio-Rad Laboratories20151—
+2K133156Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total Calibrators,Quality…Siemens Healthcare Diagnostics, Inc.20141—
+3K200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.20200—
+3K180577BioPlex 2200 25-OH Vitamin D KitBio-Rad Laboratories20180—