Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OZX · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumi | Meridian Bioscience, Inc. | 2016-06-13 | 80 | 0 |
| K152800 | illumigene Mycoplasma DNA Amplification Assay | Meridian Bioscience, Inc. | 2015-10-23 | 25 | 0 |
| K123423 | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGE | Meridian Bioscience, Inc. | 2013-06-05 | 211 | 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