FDA applicant

Osteometer Biotech A/S

Herlev, DK2 decisions1999–20010 recalls

FDA records 2 decisions for Osteometer Biotech A/S (Herlev, DK) from 1999 to 2001: 2 510(k) clearances. Most are in product codes NEO (System, Test, Osteocalcin) and JMM (Column Chromatography & Color Development…). 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 Osteometer Biotech A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Osteometer Biotech A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Osteometer Biotech A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Osteometer”

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

Osteometer Meditech A/S 3 Osteometer Meditech, Inc. 1

Osteometer Biotech A/S

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Osteometer”