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FDA 510(k)

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4

K-Number: K160647 · 2016-05-31

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2016-05-31
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-05-31 under approval number K160647. 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 IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4?

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 is a medical device that received FDA 510(k) clearance on 2016-05-31. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K160647.

When was IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 approved by the FDA?

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 received FDA 510(k) clearance on 2016-05-31, under approval number K160647.

What company makes IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4?

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4?

The FDA product code for IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 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. 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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