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FDA 510(k)

HemoScreen Hematology Analyzer

K-Number: K222148 · 2023-08-16

ApplicantPixcell Medical Technologies, Ltd.
Decision Date2023-08-16
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemoScreen Hematology Analyzer is a medical device manufactured by Pixcell Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2023-08-16 under approval number K222148. 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 HemoScreen Hematology Analyzer?

HemoScreen Hematology Analyzer is a medical device that received FDA 510(k) clearance on 2023-08-16. It is manufactured by Pixcell Medical Technologies, Ltd.. The 510(k) number is K222148.

When was HemoScreen Hematology Analyzer approved by the FDA?

HemoScreen Hematology Analyzer received FDA 510(k) clearance on 2023-08-16, under approval number K222148.

What company makes HemoScreen Hematology Analyzer?

HemoScreen Hematology Analyzer is manufactured by Pixcell Medical Technologies, Ltd..

What is the FDA product code for HemoScreen Hematology Analyzer?

The FDA product code for HemoScreen Hematology Analyzer is GKZ.

Other Devices by Pixcell Medical Technologies, Ltd.

K180020HemoScreen 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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