510(k) K932850

ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN by Helix Diagnostics, Inc. — Product Code LLL

K932850 is an FDA 510(k) premarket notification submitted by Helix Diagnostics, Inc. for the device "ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN". The FDA issued a decision of Substantially Equivalent on September 24, 1993. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Helix Diagnostics, Inc. has at least 10 other 510(k) clearances on record.