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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 K950445
Device Name VISUALINE II CANNABINOIDS (THC)
Applicant
Sun Biomedical Laboratories, Inc.
2040 Fairfax Ave.
Cherry Hill,  NJ  08003
Applicant Contact MING SUN
Correspondent
Sun Biomedical Laboratories, Inc.
2040 Fairfax Ave.
Cherry Hill,  NJ  08003
Correspondent Contact MING SUN
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received01/27/1995
Decision Date 05/02/1995
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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