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FDA 510(k) Applications for Medical Device Product Code "PCI"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K214122
Becton, Dickinson and Company
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
07/28/2022
K140111
Becton, Dickinson and Company
BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT
05/06/2014
K163571
Great Basin Scientific, Inc.
Great Basin Stool Bacterial Pathogens Panel
07/12/2017
K173330
Micronics, Inc
PanNAT STEC Test
06/01/2018
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