510(k) K803110

PROTEOLYTIC ENZYME CONTROL by American Dade — Product Code LGP

K803110 is an FDA 510(k) premarket notification submitted by American Dade for the device "PROTEOLYTIC ENZYME CONTROL". The FDA issued a decision of Substantially Equivalent on February 17, 1981. The device falls under product code LGP (Assay, Alpha-2-Antiplasmin), a Class II device regulated under 21 CFR 864.5425. American Dade has at least 10 other 510(k) clearances on record.