Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JRY — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
52 daysmedian FDA review time
266 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042118 | ATHENA MULTI-LYTE EBV IGG TEST SYSTEM | Zeus Scientific, Inc. | 2005-04-29 | 266 | 0 |
| K900974 | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | Stellar Bio Systems, Inc. | 1990-04-16 | 45 | 0 |
| K891785 | BION EBV-G (VCA) TEST SYSTEM | Bion Ent., Ltd. | 1989-08-31 | 160 | 0 |
| K884829 | EBV EARLY ANTIGEN (R+D) | Hillcrest Biologicals | 1989-04-12 | 145 | 0 |
| K822734 | EBV IGM TEST | Gull Laboratories, Inc. | 1982-12-09 | 91 | 0 |
| K822985 | EBV-M KIT | Litton Bionetics | 1982-12-03 | 52 | 0 |
| K821849 | EBV-VCA ANTIBODY ASSAY KIT | Biotech Research Laboratories, Inc. | 1982-08-12 | 50 | 0 |
| K811262 | EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI | Zeus Scientific, Inc. | 1981-05-27 | 21 | 0 |
| K780925 | EB-VCA, TEST, ANTIBODY, FLUORESCENT | Litton Bionetics | 1978-06-22 | 16 | 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