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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, Opiates
510(k) Number K014101
Device Name RAPIDONE-OXY 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 Number862.3650
Classification Product Code
DJG  
Date Received12/13/2001
Decision Date 03/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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