510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062368Substantially Equivalent

Wako Lba Dcp Test System, Model 993-05301; Dcp Control Set, Model 995-0551; Dcp Calibrator Set, Libasys, Model 999-05401

FUJIFILM Healthcare Americas Corporation, Richmond VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062368 is the FDA 510(k) clearance record for WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401, a class II device, cleared for Wako Chemicals USA, Inc. on under FDA product code OAU (Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma). FDA's definition for product code OAU reads: "The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory...". FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K062368.

Clearance record

Decision date
Received
(170 days to decision)
Product code
OAU Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
Regulation
21 CFR 866.6030
Device class
Class II
Review panel
Immunology
Applicant
Wako Chemicals USA, Inc. 1600 Bellwood Rd., Richmond VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAU

Trailing 12 months

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

FDA records show no clearances under product code OAU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OAU, 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