510(k) K904683

STRATUS PRIMIDONE FLUOROMETRIC ENZYME by Baxter Healthcare Corp — Product Code LFT

K904683 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STRATUS PRIMIDONE FLUOROMETRIC ENZYME". The FDA issued a decision of Substantially Equivalent on November 28, 1990. The device falls under product code LFT (Fluorescent Immunoassay, Primidone), a Class II device regulated under 21 CFR 862.3680. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.