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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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