510(k) Report

Devices descending from K883487

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971006Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G)Mrl Diagnostics19980—