510(k) Report

Devices descending from K022992

6 later devices reach Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103834Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control SetsBio-Rad Laboratories20120—
+1K092181Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsInstrumentation Laboratory CO20103—
+1K072032Igg Anti-Atherox Test KitCorgenix, Inc.20080—
+2K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.20240—
+2K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO20230—
+2K130528Bioplex 2200 Apls IgmBio-Rad Laboratories201301