Atellica IM Thyroglobulin (Tg)
K-Number: K242981 · 2025-06-20
ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2025-06-20
Product CodeMSW
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Atellica IM Thyroglobulin (Tg) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-06-20 under approval number K242981. The device is classified under product code MSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Atellica IM Thyroglobulin (Tg)?
Atellica IM Thyroglobulin (Tg) is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K242981.
When was Atellica IM Thyroglobulin (Tg) approved by the FDA?
Atellica IM Thyroglobulin (Tg) received FDA 510(k) clearance on 2025-06-20, under approval number K242981.
What company makes Atellica IM Thyroglobulin (Tg)?
Atellica IM Thyroglobulin (Tg) is manufactured by Siemens Healthcare Diagnostics, Inc..
What is the FDA product code for Atellica IM Thyroglobulin (Tg)?
The FDA product code for Atellica IM Thyroglobulin (Tg) is MSW.
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Official Source
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