510(k) Report

FDA applicant

Thermofisher Scientific OY

Vantaa, FI8 decisions2007–20111 recall

FDA records 8 decisions for Thermofisher Scientific OY (Vantaa, FI) from 2007 to 2011: 8 510(k) clearances. Most are in product codes CJY (Azo Dye, Calcium) and JIX (Calibrator, Multi-Analyte Mixture). Its devices cite 8 predicates, 0 of them its own earlier devices. 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 Thermofisher Scientific OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 32008: 42011: 1
2007high 4 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Thermofisher Scientific OY 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?

  • CJYAzo Dye, Calcium1decision
  • JIXCalibrator, Multi-Analyte Mixture1decision
  • CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes1decision
  • CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen1decision
  • CITNadh Oxidation/Nad Reduction, Ast/Sgot1decision
  • JFYEnzymatic Method, Creatinine1decision

Also: KHS (1), JJE (1).

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K110035IndikoThermofisher Scientific OY · 20111 recall
  • K073295Urea/Bun, Scal, Nortrol, AbtrolThermofisher Scientific OY · 2008
  • K073612Uric Acid (Aox), Scal, Nortrol, AbtrolThermofisher Scientific OY · 2008
  • K073355Calcium, Scal, Nortrol, AbtrolThermofisher Scientific OY · 2008
  • K073191Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, AbtrolThermofisher Scientific OY · 2008
  • K070824Creatinine (Enzymatic)Thermofisher Scientific OY · 2007
  • K071340Carbon Dioxide (CO2), Scal, Nortrol and AbtrolThermofisher Scientific OY · 2007
  • K071580Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolThermofisher Scientific OY · 2007

All 8 as Thermofisher Scientific OY →

What has been recalled?

1 recall linked to its devices; the latest:

  • K110035Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko…May 13, 2015Class II