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FDA 510(k) Application Details - K151213
Device Classification Name
Enzyme Immunoassay, Amphetamine
More FDA Info for this Device
510(K) Number
K151213
Device Name
Enzyme Immunoassay, Amphetamine
Applicant
UCP BIOSCIENCES, INC
1445 KOLL CIRCLE, STE 111
SAN JOSE, CA 95112 US
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Contact
NANCY CHEN
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
05/06/2015
Decision Date
08/21/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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