510(k) Report

Devices descending from K941837

19 later devices reach Roche Reagent for Creatinine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083809CreatinineAbbott Laboratories20091—
+1K072115Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and…Horiba Abx200701
+1K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HHoriba Abx2007111
+1K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx200612
+1K061193CreatinineAbbott Laboratories, Inc.20062—
+1K050283Creatinine LiquicolorStanbio Laboratory20051—
+1K981240Creatinine (Crea)Abbott Laboratories19980—
+2K210452Creatinine2Abbott Ireland Diagnostics Division20220—
+2K161527Teco Creatinine Enzymatic Reagent KitTeco Diagnostics, Inc.20170—
+2K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas20132—
+2K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas201213
+2K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas201112
+2K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+2K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx20073—
+3K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas20210—
+3K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas20190—
+3K151113ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup20150—
+3K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx200821
+4K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd.20190—