510(k) Report

Devices descending from K063520

2 later devices reach Roche Total Mycophenolic Acid Assay, Calibrators and Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102772Dimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension Mycophenolic Acid…Siemens Heatlhcare Diagnostics, Inc.20110—
+1K081083Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid ControlsThermo Fisher Scientific20080—