510(k) K190088

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents by Inova Diagnostics, Inc. — Product Code DHR

K190088 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents". The FDA issued a decision of Substantially Equivalent on April 17, 2019. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.