510(k) Report

Devices descending from K934641

4 later devices reach I-Stat Control Levels 1,2,3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982290Chem-Chex Stat (New)Streck Laboratories, Inc.19980—
+1K961195Chem-Chex StatStreck Laboratories, Inc.19962—
+2K993321R&D HGB/GLC Whole Blood ControlR&D Systems, Inc.19991—
+3K034048R&D Glu-Line Hematology ControlR&D Systems, Inc.20040—