510(k) Report

Devices descending from K023889

1 later device reach Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. NR. 1203254 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072732Ortho T. Cruzi Elisa Test SystemOrtho-Clinical Diagnostics, Inc.20090—