Class Class II
Lyra Influenza A+B Assay (K230236)
Description
Lyra Influenza A+B Assay by Quidel Corporation, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230236
Clearance Date2023-03-03
Clearance TypeSpecial
Product CodeOZE
Regulation Number866.3980
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230236
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. Lyra Influenza A+B Assay (K230236) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K131728 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Quidel Corp. | 2013 |
Trace the full predicate network for K230236
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.