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FDA 510(k) Application Details - K141410
Device Classification Name
More FDA Info for this Device
510(K) Number
K141410
Device Name
ORAGENE DX OGD-500.001
Applicant
DNA GENOTEK, INC.
2 BEAVERBROOK ROAD
OTTAWA K2K 1L1 CA
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Contact
DAN FULLERTON
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OYJ
Other 510(k) Applications for this Device
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Date Received
05/29/2014
Decision Date
02/19/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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