510(k) Report

Devices descending from K052262

5 later devices reach Quanta Lite M2 EP (MIT3) Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3)…Inova Diagnostics, Inc.20170—
+1K141375Elia M2; Immunoassay, Positive Control 100, Positive Control 250Phadia US, Inc.20151—
+1K113439Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)Euroimmun US20130—
+1K092736Euroimmun Anti-M2-3E Elisa (Igg)Euroimmun Us, Inc.20100—
+2K181556EliA M2 ImmunoassayPhadia AB20180—