510(k) Report

Devices descending from K061047

4 later devices reach Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181751HemoCue Hb 801 SystemHemocue AB20191—
+1K182298hemochroma PLUS SystemImmunostics Inc.,20180—
+1K163465hemochroma PLUS SystemImmunostics Inc.,20170—
+2K201217HemoCue Hb 301 SystemHemocue AB20200—