510(k) K834080

MATCHED COMPONENT SET FOR DIGITOXIN by Cambridge Medical Technology — Product Code LCW

K834080 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "MATCHED COMPONENT SET FOR DIGITOXIN". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code LCW (Radioimmunoassay, Digitoxin (125-I)), a Class II device regulated under 21 CFR 862.3300. Cambridge Medical Technology has at least 10 other 510(k) clearances on record.