Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioclone Australia Pty , Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
348 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935049 | ELEGANCE NEONATAL TSH ELISA | Bioclone Australia Pty , Ltd. | 1994-10-03 | 348 | 0 |
| K922284 | ELEGANCE FT4 ELISA | Bioclone Australia Pty , Ltd. | 1992-07-10 | 56 | 0 |
| K910419 | BIOCLONE'S ELEGANCE IGE ELISA KIT | Bioclone Australia Pty , Ltd. | 1991-06-21 | 142 | 0 |
| K910420 | BIOCLONE'S ELEGANCE HCG ELISA KIT | Bioclone Australia Pty , Ltd. | 1991-02-26 | 27 | 0 |
| K905099 | ELEGANCE TSH ELISA | Bioclone Australia Pty , Ltd. | 1990-12-18 | 35 | 0 |
| K905098 | ELEGANCE GH ELISA | Bioclone Australia Pty , Ltd. | 1990-12-06 | 23 | 0 |
| K904822 | ELEGANCE FERRITIN ELISA | Bioclone Australia Pty , Ltd. | 1990-11-29 | 36 | 0 |
| K904387 | BIOCLONES ELEGANCE LH ELISA KIT | Bioclone Australia Pty , Ltd. | 1990-11-06 | 42 | 0 |
| K904483 | ELEGANCE PROLACTIN ELISA | Bioclone Australia Pty , Ltd. | 1990-11-05 | 34 | 0 |
| K904405 | BIOCLONES ELEGANCE FSH ELISA KIT | Bioclone Australia Pty , Ltd. | 1990-10-26 | 31 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda