510(k) Report

Devices descending from K900078

1 later device reach Simultest Imk Plus (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K951632Ortho-Mune OK-Combo Control IGG2A-Fitc/IGG2A-PE Monoclonal Antibody (Murine)Ortho Diagnostic Systems, Inc.19970—