FDA 510(k) Application Details - DEN140039

Device Classification Name

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510(K) Number DEN140039
Device Name NOVA View Automated Fluorescense Microscope
Applicant INOVA DIAGNOSTICS, INC.
9900 OLD GROVE ROAD
SAN DIEGO, CA 92131 US
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Contact GABRIELLA LAKOS
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Regulation Number

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Classification Product Code PIV
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Date Received 12/15/2014
Decision Date 04/09/2015
Decision DENG -
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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