Class Class II
Xpert® SA Nasal Complete (K243070)
Description
Xpert® SA Nasal Complete by Cepheid®, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243070
Clearance Date2024-10-25
Clearance TypeSpecial
Product CodeNQX
Regulation Number866.1640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243070
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. Xpert® SA Nasal Complete (K243070) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K100822 | XPERT MRSA/SA NASAL ASSAY | Cepheid | 2010 |
Trace the full predicate network for K243070
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.