510(k) K971464

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT by Euro-Diagnostica AB — Product Code DBL

K971464 is an FDA 510(k) premarket notification submitted by Euro-Diagnostica AB for the device "IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT". The FDA issued a decision of Substantially Equivalent on October 29, 1997. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. Euro-Diagnostica AB has at least 5 other 510(k) clearances on record.