510(k) K992720

RAPIDONE- BENZODIAZEPINE TEST by American Bio Medica Corp. — Product Code JXM

K992720 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "RAPIDONE- BENZODIAZEPINE TEST". The FDA issued a decision of Substantially Equivalent on April 3, 2000. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.