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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, Propoxyphene
510(k) Number K030835
Device Name 'RAPID ONE' - PROPOXYPHENE 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 Number862.3700
Classification Product Code
JXN  
Date Received03/17/2003
Decision Date 05/22/2003
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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