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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 K023648
Device Name VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
Applicant
Sun Biomedical Laboratories, Inc.
604 Vpr Center
1001 Lower Landing Rd.
Blackwood,  NJ  08012
Applicant Contact MING SUN
Correspondent
Sun Biomedical Laboratories, Inc.
604 Vpr Center
1001 Lower Landing Rd.
Blackwood,  NJ  08012
Correspondent Contact MING SUN
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DJC   DJG   JXM   LCM  
Date Received10/30/2002
Decision Date 05/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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