MetaLite DX Digital Pathology Software— 510(k) K240303

Name: FDA 510(k) clearance K240303
Creator: U.S. Food and Drug Administration
Published: 2024-10-28

Substantially Equivalent

Jellox Biotech, Inc.

FDA 510(k) clearance K240303 for MetaLite DX Digital Pathology Software, Substantially Equivalent on 2024-10-28. Applicant: Jellox Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Jellox Biotech, Inc.
Product code: Code QKQ
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2024-02-02
Decision date: 2024-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu County, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.