Class Class II
K-ASSAY CRP (Ver.2) (K242170)
Description
K-ASSAY CRP (Ver.2) by Kamiya Biomedical Company, LLC, an FDA 510(k) cleared immunology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242170
Clearance Date2025-04-18
Clearance TypeTraditional
Product CodeDCK
Regulation Number866.5270
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242170
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. K-ASSAY CRP (Ver.2) (K242170) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K023828 | K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATO... | Kamiya Biomedical Co. | 2003 |
Trace the full predicate network for K242170
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.