510(k) K002268

BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST by Branan Medical Corporation — Product Code DJG

K002268 is an FDA 510(k) premarket notification submitted by Branan Medical Corporation for the device "BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST". The FDA issued a decision of Substantially Equivalent on November 27, 2000. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Branan Medical Corporation has at least 10 other 510(k) clearances on record.