510(k) Report

Devices descending from K922830

6 later devices reach Quanta Lite SS-a Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123261Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US20131—
+1K082759Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO ImmunoassayPhadia US, Inc.20091—
+1K041658Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…Bio-Rad Laboratories, Inc.200411
+2K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia AB20180—
+2K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US20140—
+2K083080Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics PlatformSqi Diagnostics Systems20090—