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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 K060760
Device Name RAPIDONE-BUPRENORPHINE TEST
Applicant
American Bio Medica Corp.
9110 Red Branch Rd.
Suite B
Columbia,  MD  21045
Applicant Contact HENRY WELLS
Correspondent
American Bio Medica Corp.
9110 Red Branch Rd.
Suite B
Columbia,  MD  21045
Correspondent Contact HENRY WELLS
Regulation Number862.3650
Classification Product Code
DJG  
Date Received03/21/2006
Decision Date 08/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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