VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534)
Description
VITROS Immunodiagnostic Products Syphilis Reagent Pack by Ortho Clinical Diagnostics, an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241534
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. VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211302 | Elecsys Syphilis | Roche Diagnostics | 2021 |
| K160910 | Elecsys Syphilis | Roche Diagnostics | 2016 |
Trace the full predicate network for K241534
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.