510(k) Report

Devices descending from K971614

3 later devices reach Quanta Lite RF Igm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102673Rheumatoid Factor Immunological Test SystemPhadia US, Inc.201111
+1K083080Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics PlatformSqi Diagnostics Systems20090—
+2K182747EliA RF IgM ImmunoassayPhadia AB201801