510(k) K192916

NOVA Lite DAPI dsDNA Crithidia luciliae Kit by Inova Diagnostics, Inc. — Product Code KTL

K192916 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "NOVA Lite DAPI dsDNA Crithidia luciliae Kit". The FDA issued a decision of Substantially Equivalent on December 11, 2020. The device falls under product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase), a Class II device regulated under 21 CFR 866.5100. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.