510(k) Report

Devices descending from K984288

5 later devices reach Vitros Chemistry Products PHBR Slides through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042476Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12…Ortho-Clinical Diagnostics, Inc.200433
+1K042520Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IiiOrtho-Clinical Diagnostics, Inc.20040—
+2K043384Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20050—
+2K043386Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc.200503
+2K042479Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…Ortho-Clinical Diagnostics, Inc.200501