510(k) K923917

ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY by Nuclear Diagnostics, Inc. — Product Code CHI

K923917 is an FDA 510(k) premarket notification submitted by Nuclear Diagnostics, Inc. for the device "ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on February 25, 1994. The device falls under product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase), a Class I device regulated under 21 CFR 862.1465. Nuclear Diagnostics, Inc. has at least 10 other 510(k) clearances on record.