FDA applicant
Bioclone Australia Pty, Ltd.
FDA records 10 decisions for Bioclone Australia Pty, Ltd. (Washington, DC) from 1990 to 1994: 10 510(k) clearances. Most are in product codes JLW (Radioimmunoassay, Thyroid-Stimulating Hormone) and CEC (Radioimmunoassay, Free Thyroxine). 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 Bioclone Australia Pty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bioclone Australia Pty, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bioclone Australia 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