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

FDA 510(k) Number Applicant Device Name Decision Date
DEN150009 B.R.A.H.M.S GMBH B.R.A.H.M.S PCT sensitive KRYPTOR 02/20/2016
K160911 bioMerieux, Inc VIDAS B.R.A.H.M.S. PCT (PCT) 06/28/2016
K200236 Ortho Clinical Diagnostics VITROS BRAHMS PCT Reagent Pack and Calibrators 02/25/2020
K160729 Roche Diagnostics Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 06/13/2016
K181002 Siemens Healthcare Diagnostics Inc. Atellica IM BRAHMS Procalcitonin (PCT) 07/16/2018


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