510(k) K952615

WAKO AUTOKIT APO A1 by Wako Chemicals USA, Inc. — Product Code JHN

K952615 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO AUTOKIT APO A1". The FDA issued a decision of Substantially Equivalent on Sep 8, 1995. The device falls under product code JHN (Turbidimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Wako Chemicals USA, Inc. has 123 other 510(k) clearances on record.