510(k) Report

Devices descending from K862386

2 later devices reach Ics Apolipoprotein B Reagent Test Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970314Synchron LX Systems Apolipoprotein (Apoa and Apob) ReagentsBeckman Instruments, Inc.19970—
+1K964010Immage Immunochemistry System Apolipoprotein a-1 Reagent (Apa)/ Immage Immunochemistry…Beckman Instruments, Inc.19970—