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FDA 510(k) Application Details - DEN180030
Device Classification Name
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510(K) Number
DEN180030
Device Name
QMS Plazomicin Immunoassay
Applicant
Microgenics Corporation
46500 Kato Road
Fremont, CA 94538 US
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Contact
Minoti Patel
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Regulation Number
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Classification Product Code
QDR
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Date Received
06/25/2018
Decision Date
11/19/2018
Decision
DENG -
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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