510(k) K063766

TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C by Good Biotech Corp. — Product Code DDG

K063766 is an FDA 510(k) premarket notification submitted by Good Biotech Corp. for the device "TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C". The FDA issued a decision of Substantially Equivalent on April 23, 2007. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Good Biotech Corp. has at least 7 other 510(k) clearances on record.