510(k) Report

FDA applicant

Macherey-Nagel-Duren

Bethesda, MD1 decision1999–19991 recall

FDA records 1 decision for Macherey-Nagel-Duren (Bethesda, MD) in 1999: 1 510(k) clearance. All are in product code JIL (Method, Enzymatic, Glucose (Urinary…). 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 Macherey-Nagel-Duren’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Macherey-Nagel-Duren since 2007.

Recalls per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Macherey-Nagel-Duren 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?

  • JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)1decision

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.

  • K991927Medi-Test Combi 11Macherey-Nagel-Duren · 19991cites it

What has FDA decided for it lately?

  • K991927Medi-Test Combi 11Macherey-Nagel-Duren · 19991 recall

The one decision as Macherey-Nagel-Duren →

What has been recalled?

1 recall linked to its devices; the latest:

  • K991927Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones…Apr 4, 2024Class II

Other applicant names beginning “Macherey-Nagel-Duren”

FDA records each applicant name separately; these may or may not be the same firm.

Macherey-Nagel GmbH & Co. KG 2