510(k) Report

FDA applicant

Labo Science-USA, Inc.

Briarcliff Manor, NY1 decision1989–19890 recalls

FDA records 1 decision for Labo Science-USA, Inc. (Briarcliff Manor, NY) in 1989: 1 510(k) clearance. All are in product code CIG (Diazo Colorimetry, Bilirubin). No 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 Labo Science-USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Labo Science-USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Labo Science-USA, 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, Bilirubin1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K871115UB Analyzer, Model UA-1/Reagent Kit/Bilirubin Con.Labo Science-USA, Inc. · 19891cites it

What has FDA decided for it lately?

  • K871115UB Analyzer, Model UA-1/Reagent Kit/Bilirubin Con.Labo Science-USA, Inc. · 1989

The one decision as Labo Science-USA, Inc. →