510(k) K883487

LYME DISEASE IFA (IGG) by Hillcrest Biologicals — Product Code LSR

K883487 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "LYME DISEASE IFA (IGG)". The FDA issued a decision of Substantially Equivalent on December 13, 1988. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Hillcrest Biologicals has at least 10 other 510(k) clearances on record.