510(k) K040445

ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE by ACON Laboratories, Inc. — Product Code JXN

K040445 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE". The FDA issued a decision of Substantially Equivalent on May 19, 2004. The device falls under product code JXN (Enzyme Immunoassay, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.