510(k) Report

Devices descending from K031942

2 later devices reach Xpect Giardia Lateral Flow Assay, Model 2450020 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120001Unigold GiardiaTrinity Biotech20130—
+1K081064Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LFIvd Research, Inc.20090—