510(k) Report

Devices descending from K951890

2 later devices reach Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983972Immulite Troponin I, Model LKTI1 and LKT15Diagnostic Products Corp.19980—
+1K964862Troponin-I Test SystemDade Intl., Inc.19970—