Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sienna Biotech, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970931 | COPALIS TORC TOTAL ANTIBODY ASSAY | Sienna Biotech, Inc. | 1997-04-24 | 48 | 0 |
| K961784 | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV | Sienna Biotech, Inc. | 1996-10-31 | 182 | 0 |
| K955799 | COPALIS CMV TOTAL ANTIBODY ASSAY | Sienna Biotech, Inc. | 1996-07-10 | 201 | 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