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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, propoxyphene
510(k) Number K020787
Device Name VERDICT-II PROPOXYPHENE
Applicant
MEDTOX DIAGNOSTICS, INC.
1238 ANTHONY RD.
BURLINGTON,  NC  27215
Applicant Contact MICHAEL TURANCHIK
Correspondent
MEDTOX DIAGNOSTICS, INC.
1238 ANTHONY RD.
BURLINGTON,  NC  27215
Correspondent Contact MICHAEL TURANCHIK
Regulation Number862.3700
Classification Product Code
JXN  
Date Received03/11/2002
Decision Date 05/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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