Class Class II
Panther Fusion AdV/hMPV/RV Assay (K231017)
Description
Panther Fusion AdV/hMPV/RV Assay by Hologic, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231017
Clearance Date2023-05-05
Clearance TypeSpecial
Product CodeOCC
Regulation Number866.3980
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231017
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. Panther Fusion AdV/hMPV/RV Assay (K231017) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172629 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2017 |
Trace the full predicate network for K231017
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.