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FDA 510(k) Application Details - K160829
Device Classification Name
More FDA Info for this Device
510(K) Number
K160829
Device Name
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DRIVE
CINCINNATI, OH 45244 US
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Contact
MICHELLE L. SMITH
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Regulation Number
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Classification Product Code
OZX
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Date Received
03/25/2016
Decision Date
06/13/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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