Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample Dilution

K100464 is the FDA 510(k) clearance record for UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION, a class II device, cleared for Wako Chemicals USA, Inc. on 2011-02-23 under FDA product code NSF (Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment). FDA's definition for product code NSF reads: "In vitro diagnostic test intended as a risk assessment test for the development of hepatocellular carcinoma (hcc) in patients with chronic liver diseases (cld). Elevated afpl3% values (= 10%) have been shown to be associated with a...". FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from 1981-06-09 to 2026-06-18. As of 2026-09-10, FDA records show 2 recalls naming K100464.