Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Pixcell Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2023-08-16 under 510(k) 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. The listed applicant is Pixcell Medical Technologies, Ltd.. The 510(k) number is K222148.

When did HemoScreen Hematology Analyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for HemoScreen Hematology Analyzer?

The FDA 510(k) record lists Pixcell Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoScreen Hematology Analyzer?

The FDA product code for HemoScreen Hematology Analyzer is GKZ.

Other records listing Pixcell Medical Technologies, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240636HemoScreen Hematology AnalyzerK180020HemoScreen Hematology Analyzer

Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K243283Alinity h-series SystemAbbott Laboratories

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.

↑