510(k) K970477

HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT by Sebia — Product Code CFE

K970477 is an FDA 510(k) premarket notification submitted by Sebia for the device "HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT". The FDA issued a decision of Substantially Equivalent on March 10, 1997. The device falls under product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Sebia has at least 10 other 510(k) clearances on record.