510(k) K013549

SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 by Sigma Diagnostics, Inc. — Product Code DAP

K013549 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971". The FDA issued a decision of Substantially Equivalent on Dec 26, 2001. The device falls under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7320. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.