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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, Methadone
510(k) Number K012164
Device Name 'RAPIDONE'-METHADONE TEST
Applicant
AMERICAN BIO MEDICA CORP.
9110 RED BRANCH RD.
COLUMBIA,  MD  21045
Applicant Contact HENRY WELLS
Correspondent
AMERICAN BIO MEDICA CORP.
9110 RED BRANCH RD.
COLUMBIA,  MD  21045
Correspondent Contact HENRY WELLS
Regulation Number862.3620
Classification Product Code
DJR  
Date Received07/11/2001
Decision Date 11/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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