Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LGI · 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) |
|---|---|---|---|---|---|
| K944063 | FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE | Sigma Diagnostics, Inc. | 1994-11-10 | 83 | 0 |
| K940682 | AXSYM(TM) QUINIDINE | Abbott Laboratories | 1994-06-21 | 131 | 4 |
| K900702 | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA | Innotron of Oregon, Inc. | 1990-04-12 | 59 | 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