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FDA 510(k) Application Details - K061005
Device Classification Name
Enzyme Immunoassay, Amphetamine
More FDA Info for this Device
510(K) Number
K061005
Device Name
Enzyme Immunoassay, Amphetamine
Applicant
APPLIED DNA TECHNOLOGIES, INC.
26251 VERONA PLACE
MISSION VIEJO, CA 92692 US
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Contact
Feng-Yu Lee
Other 510(k) Applications for this Contact
Regulation Number
862.3100
More FDA Info for this Regulation Number
Classification Product Code
DKZ
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More FDA Info for this Product Code
Date Received
04/11/2006
Decision Date
10/04/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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