510(k) Report

Devices descending from K030408

2 later devices reach Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121445Tetrachrome Reagents and Tetracxp SystemBeckman Coulter, Inc.20130—
+1K082091Tri T-Stat Reagent Assay (Dried Form) Model 25107-00Reametrix, Inc.20090—