Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sero-Immuno Diagnostics, 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) |
|---|---|---|---|---|---|
| K852286 | DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST | Sero-Immuno Diagnostics, Inc. | 1985-07-09 | 41 | 0 |
| K842181 | BETA-HCG HEMAGGLUTINATION TEST | Sero-Immuno Diagnostics, Inc. | 1984-08-22 | 82 | 0 |
| K834328 | DAT TEST FOR CHAGAS' DISEASE | Sero-Immuno Diagnostics, Inc. | 1984-03-02 | 84 | 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