510(k) K823765

ANTI SERA TO HUMAN OROSCOMUCOID by Kent Laboratories, Inc. — Product Code DEX

K823765 is an FDA 510(k) premarket notification submitted by Kent Laboratories, Inc. for the device "ANTI SERA TO HUMAN OROSCOMUCOID". The FDA issued a decision of Substantially Equivalent on December 30, 1982. The device falls under product code DEX (Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5420. Kent Laboratories, Inc. has at least 10 other 510(k) clearances on record.