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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Pressure Liquid Chromatography, Methamphetamine
510(k) Number K073078
Device Name RAPID TOX CUP
Applicant
American Bio Medica Corp.
603 Heron Dr.
Unit 3
Logan Township,  NJ  08085
Applicant Contact RICH REILLY
Correspondent
American Bio Medica Corp.
603 Heron Dr.
Unit 3
Logan Township,  NJ  08085
Correspondent Contact RICH REILLY
Regulation Number862.3610
Classification Product Code
LAG  
Subsequent Product Codes
DIO   DJG   DJR   DKE   DKZ  
JXM   JXN   LCM   LFI  
Date Received10/31/2007
Decision Date 05/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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