510(k) K013168

IMUBIND PLASMA PAI-1 ELISA,MODEL 822 by American Diagnostica, Inc. — Product Code GGP

K013168 is an FDA 510(k) premarket notification submitted by American Diagnostica, Inc. for the device "IMUBIND PLASMA PAI-1 ELISA,MODEL 822". The FDA issued a decision of Substantially Equivalent on March 7, 2002. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. American Diagnostica, Inc. has at least 9 other 510(k) clearances on record.