510(k) K150412

Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator by The Binding Site Group , Ltd. — Product Code DAE

K150412 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator". The FDA issued a decision of Substantially Equivalent on August 28, 2015. The device falls under product code DAE (Complement C9, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.