510(k) K914833

IMMULITE DIGOXIN by Cirrus Diagnostics, Inc. — Product Code DPO

K914833 is an FDA 510(k) premarket notification submitted by Cirrus Diagnostics, Inc. for the device "IMMULITE DIGOXIN". The FDA issued a decision of Substantially Equivalent on November 22, 1991. The device falls under product code DPO (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.), a Class II device regulated under 21 CFR 862.3320. Cirrus Diagnostics, Inc. has at least 9 other 510(k) clearances on record.