FDA applicant
Cel Labs Pty, Ltd.
FDA records 1 decision for Cel Labs Pty, Ltd. (Washington, DC) in 1990: 1 510(k) clearance. All are in product code LJP (Antiserum, Fluorescent, Chlamydia Trachomatis). 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 Cel Labs Pty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cel Labs Pty, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Cel Labs Pty, Ltd.’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