FDA 510(k) Applications Submitted by BARBARA MCWHORTER

FDA 510(k) Number Submission Date Device Name Applicant
K152245 08/10/2015 ONLINE TDM Vancomycin Gen.3 ROCHE DIAGNOSTICS OPERATIONS (RDO)
K162593 09/16/2016 HDL-Cholesterol Gen.4 Roche Diagnostics Operations (RDO)
K192072 08/02/2019 Tina-quant C-Reactive Protein IV Roche Diagnostics Operations (RDO)


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