510(k) K952466

OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT by Olympus America, Inc. — Product Code JHN

K952466 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT". The FDA issued a decision of Substantially Equivalent on Jun 5, 1995. The device falls under product code JHN (Turbidimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Olympus America, Inc. has 148 other 510(k) clearances on record.