510(k) K041712

'RAPIDTEC 4' TEST by American Bio Medica Corp. — Product Code DIS

K041712 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "'RAPIDTEC 4' TEST". The FDA issued a decision of Substantially Equivalent on November 3, 2004. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.