510(k) Report

FDA applicant

Wako Chemicals USA, Inc.

Richmond, VA124 decisions1981–20119 recalls

FDA records 124 decisions for Wako Chemicals USA, Inc. (Richmond, VA) from 1981 to 2011: 123 510(k) clearances and 1 De Novo grant. Most are in product codes JIT (Calibrator, Secondary) and DFC (Lipoprotein, Low-Density, Antigen, Antiserum…). Its devices cite 11 predicates, 6 of them its own earlier devices. 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Wako Chemicals USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 22008: 22011: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2021

2010: 12012: 12013: 12020: 42021: 1
2007high 4 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Wako Chemicals USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wako Chemicals USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JITCalibrator, Secondary15decisions
  • DFCLipoprotein, Low-Density, Antigen, Antiserum, Control9decisions
  • JISCalibrator, Primary7decisions
  • JIXCalibrator, Multi-Analyte Mixture4decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)4decisions
  • KNKAcid, Uric, Uricase (Colorimetric)4decisions

Also: CEK (3), CIT (3), JFM (3), CHH (3), DCK (3), JFJ (2).

Whose devices does it build on?

Its devices cite 11 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K970985Wako Total Bilirubin VWako Chemicals USA, Inc. · 19973cite it
  • K970986Wako Direct Bilirubin VWako Chemicals USA, Inc. · 19972cite it
  • K053132Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791Wako Chemicals USA, Inc. · 20052cite it
  • K003342Wako CRP-UL, CRP-UL Calibrator SetWako Chemicals USA, Inc. · 20012cite it
  • K912024Automated Biochemical Analyzer (WAK0-20R & 30R)Wako Chemicals USA, Inc. · 19912cite it
  • K062368Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys…Wako Chemicals USA, Inc. · 20071cites it

What has FDA decided for it lately?

  • K100464Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample DilutionWako Chemicals USA, Inc. · 20112 recalls
  • K080125Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and 993-25201Wako Chemicals USA, Inc. · 2008
  • K080123Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201Wako Chemicals USA, Inc. · 2008
  • K061775Wako L-Type Creatinine-M Test, and Wako Creatinine CalibratorWako Chemicals USA, Inc. · 2007
  • K062368Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys…Wako Chemicals USA, Inc. · 2007
  • K053131Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191Wako Chemicals USA, Inc. · 20051 recall
  • K053132Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791Wako Chemicals USA, Inc. · 20052 recalls
  • DEN050002Lba Afp-L3, Afp-L3 Calibrator Set, Afp-L3 Control Set and LibasysWako Chemicals USA, Inc. · 2005

All 124 as Wako Chemicals USA, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K100464¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kitFeb 18, 2021Class II
  • K001005Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C…Dec 22, 2020Class III
  • K053132Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct…Feb 13, 2020Class II
  • K053131Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total…Feb 13, 2020Class II
  • K053132ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) -…Feb 13, 2020Class II
  • K100464uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2…Apr 30, 2013Class II

Other applicant names beginning “Wako”

FDA records each applicant name separately; these may or may not be the same firm.

Wako Pure Chemical Industries, Ltd. 6Wako Intl., Inc. 4