510(k) Report

Devices descending from K053165

1 later device reach Ise Indirect NA, K, CL for Gen.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132418Cobas C 501 Ise Indirect NA, K, CL for Gen. 2Roche Diagnostics20130—