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FDA 510(k) Applications Submitted by Barbara Ann 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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