510(k) K982023

PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT by Inova Diagnostics, Inc. — Product Code DAS

K982023 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT". The FDA issued a decision of Substantially Equivalent on September 4, 1998. The device falls under product code DAS (Igg (Fc Fragment Specific), Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5530. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.