510(k) K910741

HEPARIN CONTROLS, HIGH AND LOW by Sigma Diagnostics, Inc. — Product Code KFF

K910741 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "HEPARIN CONTROLS, HIGH AND LOW". The FDA issued a decision of Substantially Equivalent on Apr 29, 1991. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.