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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 K993485
Device Name VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE
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 Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DJG   DKZ   LCM   LDJ  
Date Received10/14/1999
Decision Date 12/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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