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FDA 510(k) Application Details - K062565
Device Classification Name
Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
More FDA Info for this Device
510(K) Number
K062565
Device Name
Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
Applicant
PRINCETON BIOMEDITECH CORP.
4242 U.S. RT. 1
MONMOUTH JUNCTION, NJ 08852-1905 US
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Contact
KYUNG-AH KIM
Other 510(k) Applications for this Contact
Regulation Number
862.3220
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Classification Product Code
MKU
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More FDA Info for this Product Code
Date Received
08/31/2006
Decision Date
02/20/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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