510(k) Report

Devices descending from K922831

6 later devices reach Quanta Lite SM Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123261Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US20131—
+1K123593Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP…Inova Diagnostics, Inc.20131—
+1K041658Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…Bio-Rad Laboratories, Inc.200411
+2K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+2K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US20140—
+2K083080Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics PlatformSqi Diagnostics Systems20090—