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FDA 510(k)

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

K-Number: K162698 · 2017-07-14

ApplicantShenzhen New Industries Biomedical Engineering Co., Ltd.
Decision Date2017-07-14
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is a medical device manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2017-07-14 under approval number K162698. 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 MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K162698.

When was MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer approved by the FDA?

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer received FDA 510(k) clearance on 2017-07-14, under approval number K162698.

What company makes MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd..

What is the FDA product code for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

The FDA product code for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is JLW.

Other Devices by Shenzhen New Industries Biomedical Engineering Co., Ltd.

K182423MAGLUMI 2000 FT4 K191499MAGLUMI 2000 25-OH Vitamin D K192547MAGLUMI 2000 HCG/ß-HCG K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

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. 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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