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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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-02-08 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K233480.

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

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

Who is the listed applicant for Access SHBG?

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 SHBG?

The FDA product code for Access SHBG is CDZ.

Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: CDZ)

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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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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