510(k) K091612

UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; by Ucp Biosciences, Inc. — Product Code DJG

K091612 is an FDA 510(k) premarket notification submitted by Ucp Biosciences, Inc. for the device "UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;". The FDA issued a decision of Substantially Equivalent on February 24, 2010. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Ucp Biosciences, Inc. has at least 10 other 510(k) clearances on record.