510(k) Report

FDA applicant

D.R.G. Scientific Industries

East Boston, MA5 decisions1986–19890 recalls

FDA records 5 decisions for D.R.G. Scientific Industries (East Boston, MA) from 1986 to 1989: 5 510(k) clearances. Most are in product codes JIT (Calibrator, Secondary) and CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…). 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 D.R.G. Scientific Industries’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for D.R.G. Scientific Industries since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — D.R.G. Scientific Industries 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?

  • JITCalibrator, Secondary1decision
  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph1decision
  • FKQSystem, Dialysate Delivery, Central Multiple Patient1decision
  • FKHSolution-Test Standard-Conductivity, Dialysis1decision
  • JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide1decision

What has FDA decided for it lately?

  • K892329Osmometer Standard SolutionsD.R.G. Scientific Industries · 1989
  • K870889Acid Fuchsin SolutionsD.R.G. Scientific Industries · 1987
  • K863880Blood Gases/ PO2, PCO2 and Blood PH Analysis Prod.D.R.G. Scientific Industries · 1986
  • K863825CO-Oximeter SolutionsD.R.G. Scientific Industries · 1986
  • K863824Solution/Test Standard/Conduct. Dialy.&Mult.Solut.D.R.G. Scientific Industries · 1986

All 5 as D.R.G. Scientific Industries →