510(k) K951187

VARELISA CARDIOLIPIN ABS SCREEN by Elias U.S.A., Inc. — Product Code MID

K951187 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "VARELISA CARDIOLIPIN ABS SCREEN". The FDA issued a decision of Substantially Equivalent on October 2, 1995. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.