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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 K002447
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   DJC   DJG   JXM  
LCM   LDJ   LFI  
Date Received08/09/2000
Decision Date 11/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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