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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, Amphetamine
510(k) Number K992033
Device Name MODIFICATION TO 'RAPID DRUG SCREEN' 9-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 Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJG   JXM   LAF  
LCL   LDJ   LFG  
Date Received06/16/1999
Decision Date 06/30/1999
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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