510(k) Report

Devices descending from K951012

2 later devices reach N/T Protein Control PY through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc.199612
+2K031650Ferritin Generation 2Roche Diagnostics Corp.20030—