Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LQO — 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) |
|---|---|---|---|---|---|
| K894712 | ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION | Gen-Probe, Inc. | 1989-11-14 | 111 | 0 |
| K873670 | SNAP CAMPYLOBACTOR DIAGNOSTIC KIT | Molecular Biosystems, Inc. | 1988-06-08 | 271 | 0 |
| K875101 | VIROGEN CMV ANTIBODY TEST | Wampole Laboratories | 1988-03-01 | 82 | 0 |
| K863270 | GENE-TRAK CAMPYLOBACTER ASSAY | Integrated Genetics | 1987-08-31 | 371 | 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