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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, Barbiturate
510(k) Number K041712
Device Name 'RAPIDTEC 4' 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 Number862.3150
Classification Product Code
DIS  
Subsequent Product Codes
DJG   DJR   JXM   JXN   LFG  
Date Received06/23/2004
Decision Date 11/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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