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FDA 510(k) Application Details - DEN180040
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN180040
Device Name
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
Applicant
Meridian Bioscience, Inc.
3471 River Hills Drive
Cincinnati, OH 45244 US
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Contact
Jack Rogers
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QDZ
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More FDA Info for this Product Code
Date Received
07/30/2018
Decision Date
11/30/2018
Decision
DENG -
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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