510(k) K962198

QUANTEX C4 by Instrumentation Laboratory CO — Product Code DBI

K962198 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "QUANTEX C4". The FDA issued a decision of Substantially Equivalent on September 26, 1996. The device falls under product code DBI (Complement C4, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.