Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LGO — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
155 daysmedian FDA review time
283 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K894947 | PLATELIA TOXO IGG KIT | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-03-23 | 232 | 0 |
| K874544 | SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT | Molecular Biosystems, Inc. | 1988-08-12 | 283 | 0 |
| K791118 | HLA CONTROL SERA | Calbiochem-Behring Corp. | 1979-08-03 | 49 | 0 |
| K761008 | LYMPHOCYTE TYPING, NEGATIVE CONTROL | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 | 155 | 0 |
| K761009 | LYMPHOCYTE TYPING, POSITIVE CONTROL | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 | 155 | 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