Class Class II
Spectrum Saliva Collection Device (K223497)
Description
Spectrum Saliva Collection Device by Spectrum Solutions, LLC, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223497
Clearance Date2023-02-17
Clearance TypeTraditional
Product CodeQBD
Regulation Number866.2950
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223497
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. Spectrum Saliva Collection Device (K223497) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202641 | DNA/RNA Shield Collection Tube | Zymo Research | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240797 | PPH Saliva Collection Kit | Permantis Public Health | 2024 |
Trace the full predicate network for K223497
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.