510(k) K964152

UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH by Pharmacia, Inc. — Product Code DGC

K964152 is an FDA 510(k) premarket notification submitted by Pharmacia, Inc. for the device "UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH". The FDA issued a decision of Substantially Equivalent on April 23, 1997. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Pharmacia, Inc. has at least 10 other 510(k) clearances on record.