FDA 510(k) Applications for Medical Device Product Code "NTM"
(Antigen, Inflammatory Response Marker, Sepsis)

FDA 510(k) Number Applicant Device Name Decision Date
K071146 BIOMERIEUX, INC. VIDAS B.R.A.H.M.S. PCT ASSAY 10/11/2007
K070310 BRAHMS AKTIENGESELLSCHAFT B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM 03/31/2008
K040887 BRAHMS AKTIENGESELLSCHAFT B-R-A-H-M-S PCT LIA 01/07/2005


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