510(k) K993485

VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE by Sun Biomedical Laboratories, Inc. — Product Code DIO

K993485 is an FDA 510(k) premarket notification submitted by Sun Biomedical Laboratories, Inc. for the device "VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE". The FDA issued a decision of Substantially Equivalent on December 27, 1999. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Sun Biomedical Laboratories, Inc. has at least 10 other 510(k) clearances on record.