510(k) Report

Devices descending from K953197

5 later devices reach Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041799Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17…Ortho-Clinical Diagnostics, Inc.200423
+1K030626Vitros Chemistry Products CRP Slide and Calibrator Kit 7Ortho-Clinical Diagnostics, Inc.200313
+2K152433VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7Ortho Clinical Diagnostics201503
+2K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…Qualigen, Inc.20150—
+2K042838Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance…Ortho-Clinical Diagnostics, Inc.20040—