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FDA 510(k)

HemoScreen Hematology Analyzer

K-Number: K240636 · 2024-05-02

ApplicantPixcell Medical Technologies
Decision Date2024-05-02
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemoScreen Hematology Analyzer is a medical device manufactured by Pixcell Medical Technologies. It received FDA 510(k) clearance on 2024-05-02 under approval number K240636. 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 2024-05-02. It is manufactured by Pixcell Medical Technologies. The 510(k) number is K240636.

When was HemoScreen Hematology Analyzer approved by the FDA?

HemoScreen Hematology Analyzer received FDA 510(k) clearance on 2024-05-02, under approval number K240636.

What company makes HemoScreen Hematology Analyzer?

HemoScreen Hematology Analyzer is manufactured by Pixcell Medical Technologies.

What is the FDA product code for HemoScreen Hematology Analyzer?

The FDA product code for HemoScreen Hematology Analyzer is GKZ.

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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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