510(k) Report

Devices descending from K032203

7 later devices reach Hemocue Hemoglobin 201 + System Article 121704 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221508AnemoCheck HomeSanguina, Inc.20230—
+1K163215AnemoCheckSanguina, LLC20170—
+1K061047Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801Hemocue AB20064—
+2K181751HemoCue Hb 801 SystemHemocue AB20191—
+2K182298hemochroma PLUS SystemImmunostics Inc.,20180—
+2K163465hemochroma PLUS SystemImmunostics Inc.,20170—
+3K201217HemoCue Hb 301 SystemHemocue AB20200—