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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 K990820
Device Name RAPIDONE - OPIATES TEST
Applicant
American Bio Medica Corp.
1001 G St., NW
Suite 500 W.
Washington,  DC  20001
Applicant Contact JOHN B DUBECK
Correspondent
American Bio Medica Corp.
1001 G St., NW
Suite 500 W.
Washington,  DC  20001
Correspondent Contact JOHN B DUBECK
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DJF   DMY  
Date Received03/11/1999
Decision Date 07/15/1999
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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