Class Class II
Atellica IM Thyroglobulin (Tg) (K242981)
Description
Atellica IM Thyroglobulin (Tg) by Siemens Healthcare Diagnostics, Inc., an FDA 510(k) cleared immunology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242981
Clearance Date2025-06-20
Clearance TypeTraditional
Product CodeMSW
Regulation Number866.6010
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242981
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. Atellica IM Thyroglobulin (Tg) (K242981) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024 |
Trace the full predicate network for K242981
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.