510(k) Report

FDA applicant

Enzymatics C/O Burditt,Bowles,Radzius & Ruberry

Horsham, PA3 decisions1990–19910 recalls

FDA records 3 decisions for Enzymatics C/O Burditt,Bowles,Radzius & Ruberry (Horsham, PA) from 1990 to 1991: 3 510(k) clearances. Most are in product codes DIC (Alcohol Dehydrogenase, Specific Reagent For…) and CHH (Enzymatic Esterase--Oxidase, Cholesterol). 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 toxicology panel, where it files most

How often FDA has decided Enzymatics C/O Burditt,Bowles,Radzius & Ruberry’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Enzymatics C/O Burditt,Bowles,Radzius & Ruberry since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Enzymatics C/O Burditt,Bowles,Radzius & Ruberry 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?

  • DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method2decisions
  • CHHEnzymatic Esterase--Oxidase, Cholesterol1decision

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.

  • K894001Saliva Alcohol TestEnzymatics C/O Burditt,Bowles,Radzius & Ruberry · 19902cite it

What has FDA decided for it lately?

  • K911692Enzymatics, Inc., Total Cholesterol TestEnzymatics C/O Burditt,Bowles,Radzius & Ruberry · 1991
  • K903235Statlab a-350 Saliva Alcohol TestEnzymatics C/O Burditt,Bowles,Radzius & Ruberry · 1990
  • K894001Saliva Alcohol TestEnzymatics C/O Burditt,Bowles,Radzius & Ruberry · 1990

All 3 as Enzymatics C/O Burditt,Bowles,Radzius & Ruberry →