510(k) K782049

BIOASSAY SYSTEM, MS-2 SERUM by Abbott Laboratories — Product Code DJB

K782049 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "BIOASSAY SYSTEM, MS-2 SERUM". The FDA issued a decision of Substantially Equivalent on August 28, 1979. The device falls under product code DJB (Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.), a Class II device regulated under 21 CFR 862.3450. Abbott Laboratories has at least 10 other 510(k) clearances on record.