510(k) K830533

PHASE II DIGOXIN RADIOIMMUNOASSAY KIT by Medical & Scientific Designs, Inc. — Product Code DON

K830533 is an FDA 510(k) premarket notification submitted by Medical & Scientific Designs, Inc. for the device "PHASE II DIGOXIN RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on April 5, 1983. The device falls under product code DON (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.), a Class II device regulated under 21 CFR 862.3320. Medical & Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.