510(k) Report

Devices descending from K024098

7 later devices reach Cobas Integra Creatinine Plus Ver.2 Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183555GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+1K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…Elitechgroup20140—
+1K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc.20121—
+1K103376Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems…Seppim S.A.S.20110—
+1K070824Creatinine (Enzymatic)Thermofisher Scientific OY20070—
+2K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—
+2K200107epoc Blood Analysis SystemEpocal, Inc.2020019