510(k) K061718

INNOVACON SPECTRUM II TEST CARD by Innovacon, Inc. — Product Code DKZ

K061718 is an FDA 510(k) premarket notification submitted by Innovacon, Inc. for the device "INNOVACON SPECTRUM II TEST CARD". The FDA issued a decision of Substantially Equivalent on November 13, 2006. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Innovacon, Inc. has at least 2 other 510(k) clearances on record.