510(k) Report

Devices descending from DEN170045

5 later devices reach Banyan BTI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240279Vidas Tbi (Gfap, Uch-L1)bioMerieux, Inc.20240—
+1K223602Traumatic brain injury (TBI) testAbbott Laboratories20231—
+1K201778i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories20211—
+2K234143i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of Care20240—
+2K232669TBIAbbott Laboratories20230—