# Bioclone Australia Pty, Ltd.

- Location (FDA's records): Washington, DC
- FDA decisions: 10 (1990–1994): 10 510(k) clearances
- Product codes: JLW (2), CEC (1), CEP (1), DBF (1), DGC (1), CGJ (1), CFT (1), CFL (1), JHI (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K935049: Elegance Neonatal TSH Elisa (Oct 3, 1994)
- K922284: Elegance FT4 Elisa (Jul 10, 1992)
- K910419: Bioclone's Elegance Ige Elisa Kit (Jun 21, 1991)
- K910420: Bioclone's Elegance HCG Elisa Kit (Feb 26, 1991)
- K905099: Elegance TSH Elisa (Dec 18, 1990)
- K905098: Elegance GH Elisa (Dec 6, 1990)
- K904822: Elegance Ferritin Elisa (Nov 29, 1990)
- K904387: Bioclones Elegance LH Elisa Kit (Nov 6, 1990)

Source page: https://510kreport.com/company/bioclone-australia