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FDA 510(k) Application Details - K142156
Device Classification Name
More FDA Info for this Device
510(K) Number
K142156
Device Name
SEEGENE ANYPLEX II HSV-1/2 ASSAY
Applicant
SEEGENE
180 Cabot Street
Beverly, MA 01915 US
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Contact
FRAN WHITE
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Regulation Number
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Classification Product Code
OQO
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Date Received
08/06/2014
Decision Date
02/13/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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