Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Adi Diagnostics, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910487 | VISUWELL SYPHILIS ANTIGEN | Adi Diagnostics, Inc. | 1991-06-24 | 138 | 0 |
| K900973 | VISUWELL(R) CHLAMYDIA | Adi Diagnostics, Inc. | 1990-05-15 | 74 | 0 |
| K900338 | VISUWELL(R) REAGIN TEST (MODIFICATION) | Adi Diagnostics, Inc. | 1990-04-10 | 77 | 0 |
| K890840 | VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT | Adi Diagnostics, Inc. | 1989-03-27 | 34 | 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