510(k) Report

Devices descending from K981237

12 later devices reach Quanta Lite Ribosome P Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+1K202540EliA Rib-PPhadia AB20211—
+1K123261Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US20131—
+1K053653Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA20065—
+1K041658Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…Bio-Rad Laboratories, Inc.200411
+2K253367EliA CTD 13 ScreenPhadia AB20260—
+2K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc.20162—
+2K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US20140—
+2K083080Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics PlatformSqi Diagnostics Systems20090—
+2K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA20071—
+3K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc.20180—
+3K102607Fidistm Connective 10, Fidistm Analyzer, CarisBiomedical Diagnostics (Bmd) SA20100—