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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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