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FDA 510(k)

Access SHBG

K-Number: K233480 · 2024-02-08

ApplicantBeckman Coulter, Inc.
Decision Date2024-02-08
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access SHBG is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-02-08 under approval number K233480. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access SHBG?

Access SHBG is a medical device that received FDA 510(k) clearance on 2024-02-08. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K233480.

When was Access SHBG approved by the FDA?

Access SHBG received FDA 510(k) clearance on 2024-02-08, under approval number K233480.

What company makes Access SHBG?

Access SHBG is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access SHBG?

The FDA product code for Access SHBG is CDZ.

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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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