510(k) K962201

QUANTEX IGM by Instrumentation Laboratory CO — Product Code DFT

K962201 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "QUANTEX IGM". The FDA issued a decision of Substantially Equivalent on September 25, 1996. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.