510(k) K833623

MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY by Syva Co. — Product Code KLR

K833623 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY". The FDA issued a decision of Substantially Equivalent on Dec 8, 1983. The device falls under product code KLR (Enzyme Immunoassay, Lidocaine), a Class II device regulated under 21 CFR 862.3555. Syva Co. has at least 10 other 510(k) clearances on record.