Class Class II
Revogene (K222779)
Description
Revogene by Meridian Bioscience, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222779
Clearance Date2023-01-26
Clearance TypeSpecial
Product CodeOOI
Regulation Number862.2570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222779
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Revogene (K222779) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220480 | Revogene | Meridian Bioscience, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243922 | Revogene | Meridian Bioscience, Inc. | 2025 |
Trace the full predicate network for K222779
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.