510(k) Report

Devices descending from K003261

15 later devices reach Creatinine Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090330Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic Creatinine…Siemens Healthcare Diagnostics, Inc.200905
+1K073634Multigent Creatinine (Enzymatic) AssaySENTINEL CH. SpA200801
+1K073055Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270Dade Behring, Inc.200805
+1K070383Enzymatic Creatinine Assay (265 Series)Diagnostic Chemicals, Ltd.200722
+1K062105Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories20070—
+1K024098Cobas Integra Creatinine Plus Ver.2 AssayRoche Diagnostics Corp.200272
+2K183555GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+2K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…Elitechgroup20140—
+2K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc.20121—
+2K103376Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems…Seppim S.A.S.20110—
+2K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas201112
+2K070824Creatinine (Enzymatic)Thermofisher Scientific OY20070—
+3K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—
+3K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas20210—
+3K200107epoc Blood Analysis SystemEpocal, Inc.2020019