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510(k) K021688

NICALERT by Nymox Pharmaceutical Corporation — Product Code MRS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 18, 2002
Date Received: May 22, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Test System, Nicotine, Cotinine, Metabolites
Device Class: Class I
Regulation Number: 862.3220
Review Panel: TX
Submission Type