510(k) K971777

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

K971777 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "QUANTEX ASO-CRP-RF CONTROL". The FDA issued a decision of Substantially Equivalent on May 27, 1997. 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.