Class Class II
Tina-quant Lipoprotein(a) Gen.2 Molarity (K241220)
Description
Tina-quant Lipoprotein(a) Gen.2 Molarity by Roche Diagnostics Operations, an FDA 510(k) cleared immunology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241220
Clearance Date2025-01-24
Clearance TypeTraditional
Product CodeDFC
Regulation Number866.5600
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241220
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. Tina-quant Lipoprotein(a) Gen.2 Molarity (K241220) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K122722 | COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 058526... | Roche Diagnostics | 2012 |
Trace the full predicate network for K241220
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.