510(k) Report

Devices descending from K971205

3 later devices reach Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count Tubes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101911Immuknow-the Cylex Immune Cellfunction AssayCylex, Inc.20100—
+1K082091Tri T-Stat Reagent Assay (Dried Form) Model 25107-00Reametrix, Inc.20090—
+1K013169Immune Cell Function AssayCylex, Inc.20020—