510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN050002Unknown

Lba Afp-L3, Afp-L3 Calibrator Set, Afp-L3 Control Set and Libasys

FUJIFILM Healthcare Americas Corporation, Richmond VA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN050002 is the FDA 510(k) clearance record for LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS, a class II device, cleared for Wako Chemicals USA, Inc. on 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 to . As of , FDA records show no recalls naming DEN050002.

Clearance record

Decision date
Received
(42 days to decision)
Product code
NSF Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Regulation
21 CFR 866.6030
Device class
Class II
Review panel
Immunology
Applicant
Wako Chemicals USA, Inc. 1600 Bellwood Rd., Richmond VA
Third party review
No

Clearances, product code NSF

Trailing 12 months

FDA records hold no clearances under product code NSF in the trailing twelve months.

FDA records show no clearances under product code NSF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NSF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260