510(k) K962200

QUANTEX IGA by Instrumentation Laboratory CO — Product Code CZP

K962200 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "QUANTEX IGA". The FDA issued a decision of Substantially Equivalent on September 25, 1996. The device falls under product code CZP (Iga, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.