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FDA 510(k)

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

K-Number: K153651 · 2016-08-18

ApplicantBeckman Coulter, Inc.
Decision Date2016-08-18
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2016-08-18 under approval number K153651. 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 and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems?

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems is a medical device that received FDA 510(k) clearance on 2016-08-18. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K153651.

When was Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems approved by the FDA?

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems received FDA 510(k) clearance on 2016-08-18, under approval number K153651.

What company makes Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems?

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems?

The FDA product code for Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems is JLW.

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Related PubMed Literature

PMID: 30311376 Genetic database software as medical devices. Human mutation (2018)

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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. 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. K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerRoche Diagnostics

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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