510(k) Report

Devices descending from K970551

4 later devices reach Quanta Lite B2GPI Igg through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.20240—
+1K152875QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar…Inova Diagnostics, Inc.20150—
+1K141274Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar Anti-¿2GPI DOMAIN1; Controls.Inova Diagnostics, Inc.20150—
+1K982391Reaads Igg Anti-B2GPI Test KitCorgenix, Inc.19980—