FDA 510(k) Applications for Medical Device Product Code: PRI ()

FDA 510(k) Applications for Medical Device Product Code "PRI"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K171338	B.R.A.H.M.S GmbH	B R A H M S PCT sensitive KRYPTOR	05/31/2017
K162827	bioMerieux, Inc	VIDAS B.R.A.H.M.S. PCT (PCT)	02/23/2017
K173683	DiaSorin Inc.	LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers	02/27/2018
K170652	Fisher Diagnostics	ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls	06/01/2017
K172713	Fujirebio Diagnostics, Inc.	Lumipulse G BòRòAòHòMòS PCT Immunoreaction Cartridges, Lumipulse G BòRòAòHòMòS PCT Calibrators set	12/10/2017
K173927	Roche Diagnostics	Elecsys BRAHMS PCT	07/06/2018
K192815	Roche Diagnostics	Elecsys BRAHMS PCT	03/09/2020
K220262	Siemens Healthcare Diagnostics, Inc.	Dimension EXL LOCI BRAHMS Procalcitonin (PCT)	08/26/2022