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FDA 510(k)

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer

K-Number: K170232 · 2017-10-13

ApplicantBoditech Med, Inc.
Decision Date2017-10-13
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer is a medical device manufactured by Boditech Med, Inc.. It received FDA 510(k) clearance on 2017-10-13 under approval number K170232. 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 AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer?

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer is a medical device that received FDA 510(k) clearance on 2017-10-13. It is manufactured by Boditech Med, Inc.. The 510(k) number is K170232.

When was AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer approved by the FDA?

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer received FDA 510(k) clearance on 2017-10-13, under approval number K170232.

What company makes AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer?

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer is manufactured by Boditech Med, Inc..

What is the FDA product code for AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer?

The FDA product code for AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer is JLW.

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. 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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