510(k) Report

FDA applicant

Tech-Neal Scientific, Inc.

Westmont, IL20 decisions1988–19881 recall

FDA records 20 decisions for Tech-Neal Scientific, Inc. (Westmont, IL) in 1988: 20 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and CHH (Enzymatic Esterase--Oxidase, Cholesterol). 1 recall is 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 Tech-Neal Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tech-Neal Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tech-Neal Scientific, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CIGDiazo Colorimetry, Bilirubin2decisions
  • CHHEnzymatic Esterase--Oxidase, Cholesterol1decision
  • CHJMercuric Thiocyanate, Colorimetry, Chloride1decision
  • CKANadh Oxidation/Nad Reduction, Alt/Sgpt1decision
  • CITNadh Oxidation/Nad Reduction, Ast/Sgot1decision
  • CIXBromcresol Green Dye-Binding, Albumin1decision

Also: CGX (1), JGJ (1), CDT (1), CFR (1), CEO (1), KNK (1).

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K880236Glucose HexokinaseTech-Neal Scientific, Inc. · 19881cites it
  • K880078Urea Nitrogen (Bun)Tech-Neal Scientific, Inc. · 19881cites it

What has FDA decided for it lately?

  • K882256Magnesium Reagent SetTech-Neal Scientific, Inc. · 1988
  • K882459Diazo, Colorimetric BilirubinTech-Neal Scientific, Inc. · 1988
  • K881239Gamma Glutamyl Transferase Reagent SetTech-Neal Scientific, Inc. · 1988
  • K881241Total Bilirubin ReagentTech-Neal Scientific, Inc. · 1988
  • K880237CholesterolTech-Neal Scientific, Inc. · 19881 recall
  • K881240Chloride Reagent SetTech-Neal Scientific, Inc. · 1988
  • K881237Creatine Kinase (CK) Reagent SetTech-Neal Scientific, Inc. · 1988
  • K880277Uric Acid Reagent SetTech-Neal Scientific, Inc. · 1988

All 20 as Tech-Neal Scientific, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K880237Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250Nov 7, 2002