510(k) Report

Devices descending from K953847

6 later devices reach Roche Reagent for Glucose through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062118Pointe 360Pointe Scientific, Inc.,20070—
+1K060383GlucoseAbbott Laboratories20063—
+1K981185GLUAbbott Laboratories19980—
+2K252357Glucose2Abbott Ireland20250—
+2K170316Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories201711
+3K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…Abbott Laboratories20230—