510(k) K864333

DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY by Windsor Laboratories, Inc. — Product Code KXT

K864333 is an FDA 510(k) premarket notification submitted by Windsor Laboratories, Inc. for the device "DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on January 5, 1987. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Windsor Laboratories, Inc. has at least 10 other 510(k) clearances on record.