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FDA 510(k) Application Details - K152800
Device Classification Name
More FDA Info for this Device
510(K) Number
K152800
Device Name
illumigene Mycoplasma DNA Amplification Assay
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DRIVE
CINCINNATI, OH 45244 US
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Contact
Stefanie Johns
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Regulation Number
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Classification Product Code
OZX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/28/2015
Decision Date
10/23/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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