Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Research Diagnostics, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944876 | HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT | Research Diagnostics, Inc. | 1994-12-15 | 73 | 0 |
| K943098 | HUMAN IGG SUBCLASSES ELISA COMBI KIT | Research Diagnostics, Inc. | 1994-09-07 | 71 | 0 |
| K943205 | HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) | Research Diagnostics, Inc. | 1994-09-07 | 64 | 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