510(k) Report

Devices descending from K924898

5 later devices reach Quanta Lite (TM) SCL-70 Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsInova Diagnostics, Inc.20161—
+1K140493Elia SCL-70S ImmunoassayPhadia GmbH20140—
+1K123261Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US20131—
+2K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+2K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US20140—