Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GRE · 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) |
|---|---|---|---|---|---|
| K884004 | RUBEOLA TEST | Gull Laboratories, Inc. | 1988-12-05 | 75 | 0 |
| K853067 | FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT | Idt, A Division of Whittaker M.A. Bioproducts | 1985-10-22 | 92 | 0 |
| K821249 | ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS | Electro-Nucleonics Laboratories, Inc. | 1982-07-30 | 91 | 0 |
| K770687 | MEASLESVIRUS FLOURE. CONJUGATED ANTISERU | Microbiological Assoc. | 1977-06-14 | 62 | 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