Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stellar Bio Systems, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
328 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTE | Stellar Bio Systems, Inc. | 1999-12-22 | 142 | 0 |
| K990915 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG | Stellar Bio Systems, Inc. | 1999-04-21 | 34 | 0 |
| K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY | Stellar Bio Systems, Inc. | 1999-04-21 | 34 | 0 |
| K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | Stellar Bio Systems, Inc. | 1992-02-19 | 106 | 0 |
| K905608 | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 | Stellar Bio Systems, Inc. | 1991-11-07 | 328 | 0 |
| K900974 | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | Stellar Bio Systems, Inc. | 1990-04-16 | 45 | 0 |
| K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) | Stellar Bio Systems, Inc. | 1988-12-05 | 150 | 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