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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, Cannabinoids
510(k) Number K874390
Device Name CRACK-IT CANNABINOID SCREEN
Applicant
Sakers, Inc.
1001 Lower Landing Rd.
Blackwood,  NJ  08012
Applicant Contact AKERS, JR
Correspondent
Sakers, Inc.
1001 Lower Landing Rd.
Blackwood,  NJ  08012
Correspondent Contact AKERS, JR
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received10/27/1987
Decision Date 04/10/1989
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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