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FDA 510(k)

Access Thyroglobulin

K-Number: K220972 · 2023-09-15

ApplicantBeckman Coulter, Inc.
Decision Date2023-09-15
Product CodeMSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Access Thyroglobulin is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K220972. 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 2023-09-15. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K220972.

When did Access Thyroglobulin receive FDA 510(k) clearance?

Access Thyroglobulin received FDA 510(k) clearance on 2023-09-15, under 510(k) number K220972.

Who is the listed applicant for Access Thyroglobulin?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Access Thyroglobulin?

The FDA product code for Access Thyroglobulin is MSW.

Other records listing Beckman Coulter, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MSW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242981Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc.K240927Access ThyroglobulinBeckman Coulter, Inc.K241423Access ThyroglobulinBeckman Coulter, Inc.K221890Elecsys Tg IIRoche Diagnostics

Official Source

View on FDA Database →

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

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