510(k) Report

Devices descending from K171338

7 later devices reach B R A H M S PCT sensitive KRYPTOR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220262Dimension EXL LOCI BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.20220—
+1K200236VITROS BRAHMS PCT Reagent Pack and CalibratorsOrtho Clinical Diagnostics20200—
+1K181002Atellica IM BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.20180—
+1K173927Elecsys BRAHMS PCTRoche Diagnostics20181—
+1K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT…Fujirebio Diagnostics,Inc.20170—
+1K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S…Fisher Diagnostics20170—
+2K192815Elecsys BRAHMS PCTRoche Diagnostics20200—