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FDA 510(k)

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control

K-Number: K160541 · 2016-10-21

ApplicantSysmex America, Inc.
Decision Date2016-10-21
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control is a medical device manufactured by Sysmex America, Inc.. It received FDA 510(k) clearance on 2016-10-21 under approval number K160541. 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 Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control?

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by Sysmex America, Inc.. The 510(k) number is K160541.

When was Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control approved by the FDA?

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control received FDA 510(k) clearance on 2016-10-21, under approval number K160541.

What company makes Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control?

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control is manufactured by Sysmex America, Inc..

What is the FDA product code for Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control?

The FDA product code for Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control is JLW.

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Related PubMed Literature

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Related Devices (Code: JLW)

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. 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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