Company ยท US
Bioclone Australia Pty , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1994. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 3, 1994 | K935049 | ELEGANCE NEONATAL TSH ELISA Bioclone Australia Pty , Ltd. | JLW |
| Jul 10, 1992 | K922284 | ELEGANCE FT4 ELISA Bioclone Australia Pty , Ltd. | CEC |
| Jun 21, 1991 | K910419 | BIOCLONE'S ELEGANCE IGE ELISA KIT Bioclone Australia Pty , Ltd. | DGC |
| Feb 26, 1991 | K910420 | BIOCLONE'S ELEGANCE HCG ELISA KIT Bioclone Australia Pty , Ltd. | JHI |
| Dec 18, 1990 | K905099 | ELEGANCE TSH ELISA Bioclone Australia Pty , Ltd. | JLW |
| Dec 6, 1990 | K905098 | ELEGANCE GH ELISA Bioclone Australia Pty , Ltd. | CFL |
| Nov 29, 1990 | K904822 | ELEGANCE FERRITIN ELISA Bioclone Australia Pty , Ltd. | DBF |
| Nov 6, 1990 | K904387 | BIOCLONES ELEGANCE LH ELISA KIT Bioclone Australia Pty , Ltd. | CEP |
| Nov 5, 1990 | K904483 | ELEGANCE PROLACTIN ELISA Bioclone Australia Pty , Ltd. | CFT |
| Oct 26, 1990 | K904405 | BIOCLONES ELEGANCE FSH ELISA KIT Bioclone Australia Pty , Ltd. | CGJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||