FDA applicant
Ibl GmbH
FDA records 6 decisions for Ibl GmbH (East Stroudsburg, PA) from 2003 to 2005: 6 510(k) clearances. Most are in product codes JLS (Radioimmunoassay, Progesterone) and CZW (Complement C3, Antigen, Antiserum, Control). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ibl GmbH’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ibl GmbH since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ibl GmbH’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