510(k) K242872

iDart Lyme IgM ImmunoBlot Kit by Id-Fish Technology, Inc. — Product Code LSR

K242872 is an FDA 510(k) premarket notification submitted by Id-Fish Technology, Inc. for the device "iDart Lyme IgM ImmunoBlot Kit". The FDA issued a decision of Substantially Equivalent on June 12, 2025. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Id-Fish Technology, Inc. has at least 2 other 510(k) clearances on record.