Bioclone Australia Pty , Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Bioclone Australia Pty , Ltd.” (first 1990, latest 1994), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 36 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Immunology (2)
Most recent Bioclone Australia Pty , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935049 | ELEGANCE NEONATAL TSH ELISA | JLW | 1994-10-03 | 348 |
| K922284 | ELEGANCE FT4 ELISA | CEC | 1992-07-10 | 56 |
| K910419 | BIOCLONE'S ELEGANCE IGE ELISA KIT | DGC | 1991-06-21 | 142 |
| K910420 | BIOCLONE'S ELEGANCE HCG ELISA KIT | JHI | 1991-02-26 | 27 |
| K905099 | ELEGANCE TSH ELISA | JLW | 1990-12-18 | 35 |
| K905098 | ELEGANCE GH ELISA | CFL | 1990-12-06 | 23 |
| K904822 | ELEGANCE FERRITIN ELISA | DBF | 1990-11-29 | 36 |
| K904387 | BIOCLONES ELEGANCE LH ELISA KIT | CEP | 1990-11-06 | 42 |
| K904483 | ELEGANCE PROLACTIN ELISA | CFT | 1990-11-05 | 34 |
| K904405 | BIOCLONES ELEGANCE FSH ELISA KIT | CGJ | 1990-10-26 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Bioclone Australia Pty , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bioclone Australia Pty , Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Bioclone Australia Pty , Ltd.” (first 1990, latest 1994), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bioclone Australia Pty , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioclone Australia Pty , Ltd. is 36 days.
Which FDA product codes appear under Bioclone Australia Pty , Ltd.?
The most frequent FDA product codes under this applicant name are JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 2); CEC (Radioimmunoassay, Free Thyroxine, 1); CEP (Radioimmunoassay, Luteinizing Hormone, 1).
Next steps
- See all 10 Bioclone Australia Pty , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JLW, Bioclone Australia Pty , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.