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FDA 510(k)

XW-100 Automated Hematology Analyzer for CLIA Waived Use

K-Number: K172604 · 2017-11-06

ApplicantSysmex America, Inc.
Decision Date2017-11-06
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

XW-100 Automated Hematology Analyzer for CLIA Waived Use is a medical device manufactured by Sysmex America, Inc.. It received FDA 510(k) clearance on 2017-11-06 under approval number K172604. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XW-100 Automated Hematology Analyzer for CLIA Waived Use?

XW-100 Automated Hematology Analyzer for CLIA Waived Use is a medical device that received FDA 510(k) clearance on 2017-11-06. It is manufactured by Sysmex America, Inc.. The 510(k) number is K172604.

When was XW-100 Automated Hematology Analyzer for CLIA Waived Use approved by the FDA?

XW-100 Automated Hematology Analyzer for CLIA Waived Use received FDA 510(k) clearance on 2017-11-06, under approval number K172604.

What company makes XW-100 Automated Hematology Analyzer for CLIA Waived Use?

XW-100 Automated Hematology Analyzer for CLIA Waived Use is manufactured by Sysmex America, Inc..

What is the FDA product code for XW-100 Automated Hematology Analyzer for CLIA Waived Use?

The FDA product code for XW-100 Automated Hematology Analyzer for CLIA Waived Use is GKZ.

Other Devices by Sysmex America, Inc.

K160538Sysmex XN-L Automated Hematology Analyzer K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device K171883Sysmex UF-5000 Fully Automated Urine Particle Analyzer K182389Sysmex XN-L Automated Hematology Analyzer K210346Sysmex XW-100 Automated Hematology Analyzer

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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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