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FDA 510(k)

Elecsys TSH

K-Number: K190773 · 2019-04-16

ApplicantRoche Diagnostics
Decision Date2019-04-16
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys TSH is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2019-04-16 under approval number K190773. 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 Elecsys TSH?

Elecsys TSH is a medical device that received FDA 510(k) clearance on 2019-04-16. It is manufactured by Roche Diagnostics. The 510(k) number is K190773.

When was Elecsys TSH approved by the FDA?

Elecsys TSH received FDA 510(k) clearance on 2019-04-16, under approval number K190773.

What company makes Elecsys TSH?

Elecsys TSH is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys TSH?

The FDA product code for Elecsys TSH is JLW.

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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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