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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, Cocaine And Cocaine Metabolites
510(k) Number K950369
Device Name VISUALINE II COCAINE
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 Number862.3250
Classification Product Code
DIO  
Date Received01/31/1995
Decision Date 03/21/1995
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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