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FDA 510(k) Application Details - DEN140004
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN140004
Device Name
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
Applicant
DIAGNOSTIC HYBRIDS, INC.
2005 E State St Ste 100
ATHENS, OH 45701 US
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Contact
Ronald H Lollar
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Regulation Number
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Classification Product Code
PGI
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More FDA Info for this Product Code
Date Received
02/21/2014
Decision Date
05/13/2014
Decision
DENG -
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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