510(k) Report

FDA applicant

Analyticon Biotechnologies AG

Lichtenfels, Hessen, DE3 decisions2003–20070 recalls

FDA records 3 decisions for Analyticon Biotechnologies AG (Lichtenfels, Hessen, DE) from 2003 to 2007: 3 510(k) clearances. All are in product code JIL (Method, Enzymatic, Glucose (Urinary…). Its devices cite 3 predicates, 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 Analyticon Biotechnologies AG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Analyticon Biotechnologies AG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Analyticon Biotechnologies AG’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

Which product codes does it file in?

  • JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K061846Combi SCAN100Analyticon Biotechnologies AG · 2007
  • K061812Combi Scan 500 Urine Test Strip Analyzer, Model A93005Analyticon Biotechnologies AG · 2007
  • K023885Combi-Screen, Models 10SL and 11SLAnalyticon Biotechnologies AG · 2003

All 3 as Analyticon Biotechnologies AG →