510(k) K050576

MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H by Good Biotech Corp. — Product Code DDZ

K050576 is an FDA 510(k) premarket notification submitted by Good Biotech Corp. for the device "MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H". The FDA issued a decision of Substantially Equivalent on April 21, 2005. The device falls under product code DDZ (Albumin, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Good Biotech Corp. has at least 7 other 510(k) clearances on record.