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FDA 510(k)

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

K-Number: K221225 · 2022-11-10

ApplicantBeckman Coulter, Inc.
Decision Date2022-11-10
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer 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 2022-11-10 under 510(k) number K221225. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer?

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K221225.

When did Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer receive FDA 510(k) clearance?

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer received FDA 510(k) clearance on 2022-11-10, under 510(k) number K221225.

Who is the listed applicant for Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer?

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 TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer?

The FDA product code for Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer is JLW.

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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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