510(k) Report

Devices descending from K193419

2 later devices reach MBT Sepsityper through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251495MBT Compass HT CA Software; MBT FAST Shuttle US IVDBruker Daltonics GmbH & Co. KG20250—
+1K240854Accelerate Arc SystemAccelerate Diagnostics, Inc.20240—