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FDA 510(k)

Access Thyroglobulin Antibody II

K-Number: K213517 · 2023-09-26

ApplicantBeckman Coulter, Inc.
Decision Date2023-09-26
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Access Thyroglobulin Antibody II is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-09-26 under approval number K213517. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Thyroglobulin Antibody II?

Access Thyroglobulin Antibody II is a medical device that received FDA 510(k) clearance on 2023-09-26. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K213517.

When was Access Thyroglobulin Antibody II approved by the FDA?

Access Thyroglobulin Antibody II received FDA 510(k) clearance on 2023-09-26, under approval number K213517.

What company makes Access Thyroglobulin Antibody II?

Access Thyroglobulin Antibody II is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access Thyroglobulin Antibody II?

The FDA product code for Access Thyroglobulin Antibody II is JZO.

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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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