FDA 510(k) Applications Submitted by Nobuko Nakajima

FDA 510(k) Number Submission Date Device Name Applicant
K190433 02/22/2019 cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc.
DEN190016 03/19/2019 cobas vivoDx MRSA Roche Molecular Systems, Inc.
K071141 04/24/2007 BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 BD Biosciences
K071143 04/24/2007 BD TRITEST CD3/CD4/CD45, MODEL 340383 BD Biosciences
K081213 04/30/2008 BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 BD Biosciences
K173887 12/21/2017 cobas CT/NG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc.


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