510(k) Report

Devices descending from K923166

6 later devices reach Vidas Toxoplasma Gondii Igm Asssay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233932Alinity i Toxo IgMAbbott Laboratories20240—
+1K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics20170—
+1K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM…Bio-Rad Laboratories20170—
+1K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux201504
+1K101946Vidas Toxo Igg AviditybioMerieux, Inc.201101
+1K012075Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model…Diagnostic Products Corp.20020—