Class Class II
DISINTEK™ PA Test Strips (K251035)
Description
DISINTEK™ PA Test Strips by Serim Research, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251035
Clearance Date2025-06-03
Clearance TypeTraditional
Product CodeJOJ
Regulation Number880.2800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251035
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. DISINTEK™ PA Test Strips (K251035) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K152394 | Rapicide PA High-Level Disinfectant Test Strips | Medivators, Inc. | 2016 |
Trace the full predicate network for K251035
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.