Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GNY · 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) |
|---|---|---|---|---|---|
| K922801 | RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | 1993-01-06 | 210 | 0 |
| K885310 | MURINE MONOCLONAL ANTI-ADENOVIRUS IGG | Whittaker Bioproducts, Inc. | 1989-02-16 | 49 | 0 |
| K770811 | ADENOVIRUS GROUP-FA LABELLED PRESERUM | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770807 | ADENOVIRUS-GROUP FA LABELLED (8-651 RF) | Flow Laboratories, Inc. | 1977-05-20 | 17 | 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