FDA 510(k) Application Details - K152800

Device Classification Name

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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
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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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