510(k) Report

Devices descending from K913618

2 later devices reach Arbovirus Igm Ifa Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040854West Nile Virus Igm Capture ElisaFocus Technologies, Inc.20041—
+2K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc.20160—