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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Nicotine, Cotinine, Metabolites
510(k) Number K021688
Device Name NICALERT
Applicant
Nymox Pharmaceutical Corporation
230 W. Passaic St.
Maywood,  NJ  07607
Applicant Contact MICHAEL MUNZAR
Correspondent
Nymox Pharmaceutical Corporation
230 W. Passaic St.
Maywood,  NJ  07607
Correspondent Contact MICHAEL MUNZAR
Regulation Number862.3220
Classification Product Code
MRS  
Subsequent Product Code
DIF  
Date Received05/22/2002
Decision Date 10/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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