510(k) K930421

ELIAS DSDNA ABS by Elias U.S.A., Inc. — Product Code DHC

K930421 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "ELIAS DSDNA ABS". The FDA issued a decision of Substantially Equivalent on March 10, 1993. The device falls under product code DHC (System, Test, Systemic Lupus Erythematosus), a Class II device regulated under 21 CFR 866.5820. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.