510(k) K163101

CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set by Microgenics Corporation — Product Code DJG

K163101 is an FDA 510(k) premarket notification submitted by Microgenics Corporation for the device "CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set". The FDA issued a decision of Substantially Equivalent on April 6, 2017. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Microgenics Corporation has at least 10 other 510(k) clearances on record.