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FDA 510(k) Applications Submitted by Stefanie Johns
FDA 510(k) Number
Submission Date
Device Name
Applicant
K151046
04/20/2015
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
MERIDIAN BIOSCIENCE, INC.
K152800
09/28/2015
illumigene Mycoplasma DNA Amplification Assay
MERIDIAN BIOSCIENCE, INC.
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