Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NCW · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | Bayer Corp. | 2003-01-30 | 57 | 0 |
| K994112 | MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) | Oncogene Science, Inc. | 2000-09-29 | 298 | 0 |
| K992228 | BAYER IMMUNO 1 HER-2/NEU ASSAY | Bayer Corp. | 2000-09-29 | 455 | 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