510(k) Report

Devices descending from K091556

3 later devices reach Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.20240—
+1K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO20230—
+1K130528Bioplex 2200 Apls IgmBio-Rad Laboratories201301