510(k) K023648

VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI by Sun Biomedical Laboratories, Inc. — Product Code LDJ

K023648 is an FDA 510(k) premarket notification submitted by Sun Biomedical Laboratories, Inc. for the device "VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI". The FDA issued a decision of Substantially Equivalent on May 6, 2003. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Sun Biomedical Laboratories, Inc. has at least 10 other 510(k) clearances on record.