510(k) Report

Devices descending from K883767

1 later device reach Lyme Disease Ifa (Igm) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971007Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M)Mrl Diagnostics19980—