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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 K023869
Device Name 'RAPIDTEC'-5M-MULTIPLE DIP 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  
Subsequent Product Codes
DIG   JXM   LCM   LDJ  
Date Received11/20/2002
Decision Date 04/30/2003
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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