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510(k) K062565

STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE by Princeton BioMeditech Corp. — Product Code MKU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2007
Date Received
August 31, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
Submission Type

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  • K972481 — AUTO-LYTE COTININE EIA (October 21, 1997)