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

FDA 510(k) Number Applicant Device Name Decision Date
K181663 GenMark Diagnostics, Incorporated ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel 12/20/2018
K152470 GREAT BASIN SCIENTIFIC, INC. Great Basin Staph ID/R Blood Culture Panel 03/25/2016
K163390 iCubate, Inc iC-GPC Assay TM for use on the iC-SystemTM 08/08/2017
DEN120014 NANOSPHERE, INC VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) 06/26/2012
K122514 NANOSPHERE, INC VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST 09/19/2012


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