510(k) K030835

'RAPID ONE' - PROPOXYPHENE TEST by American Bio Medica Corp. — Product Code JXN

K030835 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "'RAPID ONE' - PROPOXYPHENE TEST". The FDA issued a decision of Substantially Equivalent on May 22, 2003. The device falls under product code JXN (Enzyme Immunoassay, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.