510(k) K121045

HUMAN ALBUMIN CSF KIT by The Binding Site Group , Ltd. — Product Code DCF

K121045 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "HUMAN ALBUMIN CSF KIT". The FDA issued a decision of Substantially Equivalent on June 19, 2013. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.