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FDA 510(k)

Access TPO Antibody

K-Number: K240469 · 2024-08-09

ApplicantBeckman Coulter, Inc.
Decision Date2024-08-09
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Access TPO Antibody is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-08-09 under approval number K240469. 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 TPO Antibody?

Access TPO Antibody is a medical device that received FDA 510(k) clearance on 2024-08-09. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K240469.

When was Access TPO Antibody approved by the FDA?

Access TPO Antibody received FDA 510(k) clearance on 2024-08-09, under approval number K240469.

What company makes Access TPO Antibody?

Access TPO Antibody is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access TPO Antibody?

The FDA product code for Access TPO Antibody is JZO.

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Related Devices (Code: 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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