510(k) Report

Devices descending from K973030

2 later devices reach Vitros Immunodiagnostics Products/CK-MB Reagent Pack (Gem.1300)/CK-MB… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993068Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic Products…Ortho-Clinical Diagnostics199911
+2K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics20220—