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FDA 510(k)

Access Thyroglobulin

K-Number: K241423 · 2024-06-07

Decision Date2024-06-07
Product CodeMSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Access Thyroglobulin is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-06-07 under approval number K241423. 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 Access Thyroglobulin?

Access Thyroglobulin is a medical device that received FDA 510(k) clearance on 2024-06-07. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K241423.

When was Access Thyroglobulin approved by the FDA?

Access Thyroglobulin received FDA 510(k) clearance on 2024-06-07, under approval number K241423.

What company makes Access Thyroglobulin?

Access Thyroglobulin is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access Thyroglobulin?

The FDA product code for Access Thyroglobulin is MSW.

Other Devices by Beckman Coulter, Inc.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.