510(k) Report

Devices descending from K921661

2 later devices reach Boehringer Mannheim/ Hitachi 911 Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111188Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack…Roche Diagnostics201204
+1K113521Calcium Gen. 2Roche Diagnostics20120—