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FDA 510(k) Application Details - K110701
Device Classification Name
More FDA Info for this Device
510(K) Number
K110701
Device Name
ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
Applicant
DNA GENOTEK INC
2 BEAVERBROOK ROAD
OTTAWA ONTARIO K2K 1L1 CA
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Contact
CHANTAL HEMENS-DAVIS
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OYJ
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Date Received
03/14/2011
Decision Date
12/02/2011
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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