510(k) K022195

COAMATIC AT-400 by Instrumentation Laboratory CO — Product Code JBQ

K022195 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "COAMATIC AT-400". The FDA issued a decision of Substantially Equivalent on August 7, 2002. The device falls under product code JBQ (Antithrombin Iii Quantitation), a Class II device regulated under 21 CFR 864.7060. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.