Class Class II
PPH Saliva Collection Kit (K240797)
Description
PPH Saliva Collection Kit by Permantis Public Health, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240797
Clearance Date2024-10-11
Clearance TypeTraditional
Product CodeQBD
Regulation Number866.2950
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240797
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. PPH Saliva Collection Kit (K240797) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223497 | Spectrum Saliva Collection Device | Spectrum Solutions, LLC | 2023 |
Trace the full predicate network for K240797
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.