510(k) Report

Devices descending from K990595

1 later device reach Integra Reagent Cassette for Apolipoprotein B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013207Tina-Quant Apolipoprotein B Ver.2Roche Diagnostics Corp.20010—