FDA applicant

Macherey-Nagel GmbH & Co. KG

Rockville, MD2 decisions2005–20060 recalls

FDA records 2 decisions for Macherey-Nagel GmbH & Co. KG (Rockville, MD) from 2005 to 2006: 2 510(k) clearances. All are in product code JIL (Method, Enzymatic, Glucose (Urinary…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Macherey-Nagel GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Macherey-Nagel GmbH & Co. KG since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Macherey-Nagel GmbH & Co. KG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Macherey-Nagel GmbH & Co. KG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Macherey-Nagel”

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

Macherey-Nagel-Duren 1

Macherey-Nagel GmbH & Co. KG

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Macherey-Nagel”