510(k) K760143

SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN by Oxford Laboratories, Inc. — Product Code DEX

K760143 is an FDA 510(k) premarket notification submitted by Oxford Laboratories, Inc. for the device "SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code DEX (Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5420. Oxford Laboratories, Inc. has at least 8 other 510(k) clearances on record.