510(k) K984437

QUANTEX ASO-CRP-RP CONTROL II by Instrumentation Laboratory CO — Product Code JJT

K984437 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "QUANTEX ASO-CRP-RP CONTROL II". The FDA issued a decision of Substantially Equivalent on February 2, 1999. The device falls under product code JJT (Enzyme Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.