510(k) K061598

HEMOSIL HOMOCYSTEINE AND CONTROLS by Instrumentation Laboratory CO — Product Code LPS

K061598 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL HOMOCYSTEINE AND CONTROLS". The FDA issued a decision of Substantially Equivalent on September 22, 2006. The device falls under product code LPS (Urinary Homocystine (Nonquantitative) Test System), a Class II device regulated under 21 CFR 862.1377. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.