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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, Cocaine And Cocaine Metabolites
510(k) Number K980872
Device Name RAPID DRUG SCREEN' 8 PANEL
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 Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DIS   DJG   DKZ   JXM   LAF  
LCM   LDJ  
Date Received03/06/1998
Decision Date 03/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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