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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 a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2022-11-10 under approval 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. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K221225.

When was Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer approved by the FDA?

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

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

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer is manufactured by Beckman Coulter, Inc..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41453730 Validation of the SOPHiA DDM HRD Solution as a Companion Diagnostic for Poly (ADP-Ribose) Polymerase Inhibitor Access in Australia. The Journal of molecular diagnostics : JMD (2026)

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Related Devices (Code: JLW)

K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi ControlSysmex America, Inc. K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc. K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc. K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerBoditech Med, Inc. K171103Lumipulse G TSH-III Immunoreaction CartridgesFujirebio Diagnostics,Inc. K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.

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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