Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LHK — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893753 | DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-16 | 150 | 0 |
| K823016 | CANDIDA DETECTION SYSTEM | Ramco Laboratories, Inc. | 1982-12-28 | 77 | 0 |
| K812741 | REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS | Nolan Biological Laboratories, Inc. | 1981-10-23 | 24 | 0 |
| K812186 | CANDIDA IMMUNODIFFUSION SYSTEM | American Scientific Products | 1981-08-25 | 22 | 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