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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Cocaine
510(k) Number K874389
Device Name CRACK-IT CHAP SCREEN
Applicant
Sakers, Inc.
Plaza 47
800 Delsea Dr., Suite 10
Westville,  NJ  08093
Applicant Contact AKERS, JR
Correspondent
Sakers, Inc.
Plaza 47
800 Delsea Dr., Suite 10
Westville,  NJ  08093
Correspondent Contact AKERS, JR
Regulation Number862.3250
Classification Product Code
DMN  
Date Received10/27/1987
Decision Date 02/07/1989
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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