510(k) K023869

'RAPIDTEC'-5M-MULTIPLE DIP TEST by American Bio Medica Corp. — Product Code DJR

K023869 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "'RAPIDTEC'-5M-MULTIPLE DIP TEST". The FDA issued a decision of Substantially Equivalent on April 30, 2003. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.