510(k) K822677

FITC ANTISERA TO HUMAN IGM by Amico Lab, Inc. — Product Code DFH

K822677 is an FDA 510(k) premarket notification submitted by Amico Lab, Inc. for the device "FITC ANTISERA TO HUMAN IGM". The FDA issued a decision of Substantially Equivalent on November 17, 1982. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Amico Lab, Inc. has at least 10 other 510(k) clearances on record.