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FDA 510(k)

MetaLite DX Digital Pathology Software

K-Number: K240303 · 2024-10-28

ApplicantJellox Biotech, Inc.
Decision Date2024-10-28
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

MetaLite DX Digital Pathology Software is the device name listed in this FDA 510(k) record. The listed applicant is Jellox Biotech, Inc.. It received FDA 510(k) clearance on 2024-10-28 under 510(k) number K240303. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MetaLite DX Digital Pathology Software?

MetaLite DX Digital Pathology Software is a medical device that received FDA 510(k) clearance on 2024-10-28. The listed applicant is Jellox Biotech, Inc.. The 510(k) number is K240303.

When did MetaLite DX Digital Pathology Software receive FDA 510(k) clearance?

MetaLite DX Digital Pathology Software received FDA 510(k) clearance on 2024-10-28, under 510(k) number K240303.

Who is the listed applicant for MetaLite DX Digital Pathology Software?

The FDA 510(k) record lists Jellox Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MetaLite DX Digital Pathology Software?

The FDA product code for MetaLite DX Digital Pathology Software is QKQ.

Related Devices (Code: QKQ)

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.

K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc.K261380Concentriq AP-DxProscia, Inc.K243449INFINITT DPSInfinitt Healthcare Co., Ltd.K252762HALO AP DxIndica Labs, LLCK243391AISight DxPathAI, Inc.K250968PathPresenter Clinical ViewerPathpresenter Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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