510(k) K014101

RAPIDONE-OXY TEST by American Bio Medica Corp. — Product Code DJG

K014101 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "RAPIDONE-OXY TEST". The FDA issued a decision of Substantially Equivalent on March 20, 2002. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.